calendar no. 121 s s. 697 · 2 •s 697 rs 1 section 1. short title. 2 this act may be cited as the...

II

Calendar No. 121 114TH CONGRESS

1ST SESSION S. 697 To amend the Toxic Substances Control Act to reauthorize and modernize

that Act, and for other purposes.

IN THE SENATE OF THE UNITED STATES

MARCH 10, 2015

Mr. UDALL (for himself, Mr. VITTER, Mr. MANCHIN, Mr. INHOFE, Mr. CAR-

PER, Mr. BLUNT, Mr. COONS, Mr. BOOZMAN, Mr. DONNELLY, Mrs. CAP-

ITO, Mr. HEINRICH, Mr. CASSIDY, Ms. HEITKAMP, Mr. CRAPO, Ms. STA-

BENOW, Mr. HOEVEN, Mr. PORTMAN, Mr. WARNER, Mr. PETERS, Mr.

ROUNDS, Mr. BROWN, Mr. THUNE, Mr. BARRASSO, Mr. BOOKER, Mr.

CORNYN, Mr. COTTON, Mr. ISAKSON, Mr. KAINE, Mrs. MCCASKILL, Mr.

MERKLEY, Ms. MURKOWSKI, Mr. MURPHY, Mr. RUBIO, Mr. SCOTT, Mrs.

SHAHEEN, Mr. WHITEHOUSE, Mr. CASEY, Mr. PERDUE, Ms. KLO-

BUCHAR, Mr. COATS, and Mr. TOOMEY) introduced the following bill;

which was read twice and referred to the Committee on Environment and

Public Works

JUNE 17, 2015

Reported by Mr. INHOFE, with an amendment

[Strike out all after the enacting clause and insert the part printed in italic]

A BILL To amend the Toxic Substances Control Act to reauthorize

and modernize that Act, and for other purposes.

Be it enacted by the Senate and House of Representa-1

tives of the United States of America in Congress assembled, 2

VerDate Sep 11 2014 21:05 Jun 17, 2015 Jkt 049200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S697.RS S697asab

alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

2

•S 697 RS

SECTION 1. SHORT TITLE. 1

This Act may be cited as the ‘‘Frank R. Lautenberg 2

Chemical Safety for the 21st Century Act’’. 3

SEC. 2. FINDINGS, POLICY, AND INTENT. 4

Section 2(c) of the Toxic Substances Control Act (15 5

U.S.C. 2601(c)) is amended— 6

(1) by striking ‘‘It is the intent’’ and inserting 7

the following: 8

‘‘(1) ADMINISTRATION.—It is the intent’’; 9

(2) in paragraph (1) (as so redesignated), by 10

inserting ‘‘, as provided under this Act’’ before the 11

period at the end; and 12

(3) by adding at the following: 13

‘‘(2) REFORM.—It is the intent of Congress 14

that reform of this Act in accordance with the 15

amendments made by the Frank R. Lautenberg 16

Chemical Safety for the 21st Century Act— 17

‘‘(A) shall be administered in a manner 18

that— 19

‘‘(i) protects the health of children, 20

pregnant women, the elderly, workers, con-21

sumers, the general public, and the envi-22

ronment from the risks of harmful expo-23

sures to chemical substances and mixtures; 24

and 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

3

•S 697 RS

‘‘(ii) ensures that appropriate infor-1

mation on chemical substances and mix-2

tures is available to public health officials 3

and first responders in the event of an 4

emergency; and 5

‘‘(B) shall not displace or supplant com-6

mon law rights of action or remedies for civil 7

relief.’’. 8

SEC. 3. DEFINITIONS. 9

Section 3 of the Toxic Substances Control Act (15 10

U.S.C. 2602) is amended— 11

(1) by redesignating paragraphs (4), (5), (6), 12

(7), (8), (9), (10), (11), (12), (13), and (14) as 13

paragraphs (5), (6), (7), (8), (9), (10), (12), (13), 14

(17), (18), and (19), respectively; 15

(2) by inserting after paragraph (3) the fol-16

lowing: 17

‘‘(4) CONDITIONS OF USE.—The term ‘condi-18

tions of use’ means the intended, known, or reason-19

ably foreseeable circumstances the Administrator de-20

termines a chemical substance is manufactured, 21

processed, distributed in commerce, used, or dis-22

posed of.’’; 23

(3) by inserting after paragraph (10) (as so re-24

designated) the following: 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

4

•S 697 RS

‘‘(11) POTENTIALLY EXPOSED OR SUSCEPTIBLE 1

POPULATION.—The term ‘potentially exposed or sus-2

ceptible population’ means 1 or more groups— 3

‘‘(A) of individuals within the general pop-4

ulation who may be— 5

‘‘(i) differentially exposed to chemical 6

substances under the conditions of use; or 7

‘‘(ii) susceptible to greater adverse 8

health consequences from chemical expo-9

sures than the general population; and 10

‘‘(B) that when identified by the Adminis-11

trator may include such groups as infants, chil-12

dren, pregnant women, workers, and the elder-13

ly.’’; and 14



‘‘(14) SAFETY ASSESSMENT.—The term ‘safety 17

assessment’ means an assessment of the risk posed 18

by a chemical substance under the conditions of use, 19

integrating hazard, use, and exposure information 20

regarding the chemical substance. 21

‘‘(15) SAFETY DETERMINATION.—The term 22

‘safety determination’ means a determination by the 23

Administrator as to whether a chemical substance 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

5

•S 697 RS

meets the safety standard under the conditions of 1

use. 2

‘‘(16) SAFETY STANDARD.—The term ‘safety 3

standard’ means a standard that ensures, without 4

taking into consideration cost or other nonrisk fac-5

tors, that no unreasonable risk of harm to health or 6

the environment will result from exposure to a chem-7

ical substance under the conditions of use, including 8

no unreasonable risk of harm to— 9

‘‘(A) the general population; or 10

‘‘(B) any potentially exposed or susceptible 11

population that the Administrator has identified 12

as relevant to the safety assessment and safety 13

determination for a chemical substance.’’. 14

SEC. 4. POLICIES, PROCEDURES, AND GUIDANCE. 15

The Toxic Substances Control Act is amended by in-16

serting after section 3 (15 U.S.C. 2602) the following: 17

‘‘SEC. 3A. POLICIES, PROCEDURES, AND GUIDANCE. 18

‘‘(a) DEFINITION OF GUIDANCE.—In this section, the 19

term ‘guidance’ includes any significant written guidance 20

of general applicability prepared by the Administrator. 21

‘‘(b) DEADLINE.—Not later than 2 years after the 22

date of enactment of the Frank R. Lautenberg Chemical 23

Safety for the 21st Century Act, the Administrator shall 24

develop, after providing public notice and an opportunity 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

6

•S 697 RS

for comment, any policies, procedures, and guidance the 1

Administrator determines to be necessary to carry out sec-2

tions 4, 4A, 5, and 6, including the policies, procedures, 3

and guidance required by this section. 4

‘‘(c) USE OF SCIENCE.— 5

‘‘(1) IN GENERAL.—The Administrator shall es-6

tablish policies, procedures, and guidance on the use 7

of science in making decisions under sections 4, 4A, 8

5, and 6. 9

‘‘(2) GOAL.—A goal of the policies and proce-10

dures described in paragraph (1) shall be to make 11

the basis of decisions clear to the public. 12

‘‘(3) REQUIREMENTS.—The policies, proce-13

dures, and guidance issued under this section shall 14

describe the manner in which the Administrator 15

shall ensure that— 16

‘‘(A) decisions made by the Adminis-17

trator— 18

‘‘(i) are based on information, proce-19

dures, measures, methods, and models em-20

ployed in a manner consistent with the 21

best available science; 22

‘‘(ii) take into account the extent to 23

which— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

7

•S 697 RS

‘‘(I) assumptions and methods 1

are clearly and completely described 2

and documented; 3

‘‘(II) variability and uncertainty 4

are evaluated and characterized; and 5

‘‘(III) the information has been 6

subject to independent verification 7

and peer review; and 8

‘‘(iii) are based on the weight of the 9

scientific evidence, by which the Adminis-10

trator considers all information in a sys-11

tematic and integrative framework to con-12

sider the relevance of different informa-13

tion; 14

‘‘(B) to the extent practicable and if ap-15

propriate, the use of peer review, standardized 16

test design and methods, consistent data eval-17

uation procedures, and good laboratory prac-18

tices will be encouraged; 19

‘‘(C) a clear description of each individual 20

and entity that funded the generation or assess-21

ment of information, and the degree of control 22

those individuals and entities had over the gen-23

eration, assessment, and dissemination of infor-24

mation (including control over the design of the 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

8

•S 697 RS

work and the publication of information) is 1

made available; and 2

‘‘(D) if appropriate, the recommendations 3

in reports of the National Academy of Sciences 4

that provide advice regarding assessing the haz-5

ards, exposures, and risks of chemical sub-6

stances are considered. 7

‘‘(d) EXISTING EPA POLICIES, PROCEDURES, AND 8

GUIDANCE.—The policies, procedures, and guidance de-9

scribed in subsection (b) shall incorporate, as appropriate, 10

existing relevant hazard, exposure, and risk assessment 11

guidelines and methodologies, data evaluation and quality 12

criteria, testing methodologies, and other relevant guide-13

lines and policies of the Environmental Protection Agency. 14

‘‘(e) REVIEW.—Not later than 5 years after the date 15

of enactment of this section, and not less frequently than 16

once every 5 years thereafter, the Administrator shall— 17

‘‘(1) review the adequacy of any policies, proce-18

dures, and guidance developed under this section, in-19

cluding animal, nonanimal, and epidemiological test 20

methods and procedures for assessing and deter-21

mining risk under this Act; and 22

‘‘(2) after providing public notice and an oppor-23

tunity for comment, revise the policies, procedures, 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

9

•S 697 RS

and guidance if necessary to reflect new scientific 1

developments or understandings. 2

‘‘(f) SOURCES OF INFORMATION.—In making any de-3

cision with respect to a chemical substance under section 4

4, 4A, 5, or 6, the Administrator shall take into consider-5

ation information relating to the hazards and exposures 6

of a chemical substance under the conditions of use that 7

is reasonably available to the Administrator, including in-8

formation that is— 9

‘‘(1) submitted to the Administrator pursuant 10

to any rule, consent agreement, order, or other re-11

quirement of this Act, or on a voluntary basis, in-12

cluding pursuant to any request made under this 13

Act, by— 14

‘‘(A) manufacturers or processors of a sub-15

stance; 16

‘‘(B) the public; 17

‘‘(C) other Federal departments or agen-18

cies; or 19

‘‘(D) the Governor of a State or a State 20

agency with responsibility for protecting health 21

or the environment; 22

‘‘(2) submitted to a governmental entity in any 23

jurisdiction pursuant to a governmental requirement 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

10

•S 697 RS

relating to the protection of health or the environ-1

ment; or 2

‘‘(3) identified through an active search by the 3

Administrator of information sources that are pub-4

licly available or otherwise accessible by the Admin-5

istrator. 6

‘‘(g) TESTING OF CHEMICAL SUBSTANCES AND MIX-7

TURES.— 8


tablish policies and procedures for the testing of 10

chemical substances or mixtures under section 4. 11


dures established under paragraph (1) shall be to 13

make the basis of decisions clear to the public. 14

‘‘(3) CONTENTS.—The policies and procedures 15

established under paragraph (1) shall— 16

‘‘(A) address how and when the exposure 17

level or exposure potential of a chemical sub-18

stance would factor into decisions to require 19

new testing, subject to the condition that the 20

Administrator shall not interpret the lack of ex-21

posure information as a lack of exposure or ex-22

posure potential; 23

‘‘(B) describe the manner in which the Ad-24

ministrator will determine that additional infor-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

11

•S 697 RS

mation is necessary to carry out this Act, in-1

cluding information relating to potentially ex-2

posed or susceptible populations; 3

‘‘(C) require the Administrator to consult 4

with the Director of the National Institute for 5

Occupational Safety and Health prior to pre-6

scribing epidemiologic studies of employees; and 7

‘‘(D) prior to adopting a requirement for 8

testing using vertebrate animals, require the 9

Administrator to take into consideration, as ap-10

propriate and to the extent practicable, reason-11

ably available— 12

‘‘(i) toxicity information; 13

‘‘(ii) computational toxicology and 14

bioinformatics; 15

‘‘(iii) high-throughput screening meth-16

ods and the prediction models of those 17

methods; and 18

‘‘(iv) scientifically reliable and rel-19

evant alternatives to tests on animals that 20

would provide equivalent information. 21

‘‘(4) TIERED TESTING.— 22

‘‘(A) IN GENERAL.—Except as provided in 23

subparagraph (D), the Administrator shall em-24

ploy a tiered screening and testing process, 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

12

•S 697 RS

under which the results of screening-level tests 1

or assessments of available information inform 2

the decision as to whether 1 or more additional 3

tests are necessary. 4

‘‘(B) SCREENING-LEVEL TESTS.— 5

‘‘(i) IN GENERAL.—The screening- 6

level tests required for a chemical sub-7

stance or mixture may include tests for 8

hazard (which may include in silico, in 9

vitro, and in vivo tests), environmental and 10

biological fate and transport, and measure-11

ments or modeling of exposure or exposure 12

potential, as appropriate. 13

‘‘(ii) USE.—Screening-level tests shall 14

be used— 15

‘‘(I) to screen chemical sub-16

stances or mixtures for potential ad-17

verse effects; and 18

‘‘(II) to inform a decision of the 19

Administrator regarding whether 20

more complex or targeted additional 21

testing is necessary. 22

‘‘(C) ADDITIONAL TESTING.—If the Ad-23

ministrator determines under subparagraph (B) 24

that additional testing is necessary to provide 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

13

•S 697 RS

more definitive information for safety assess-1

ments or safety determinations, the Adminis-2

trator may require more advanced tests for po-3

tential health or environmental effects or expo-4

sure potential. 5

‘‘(D) ADVANCED TESTING WITHOUT 6

SCREENING.—The Administrator may require 7

more advanced testing without conducting 8

screening-level testing when other information 9

available to the Administrator justifies the ad-10

vanced testing, pursuant to guidance developed 11

by the Administrator under this section. 12

‘‘(h) SAFETY ASSESSMENTS AND SAFETY DETER-13

MINATIONS.— 14

‘‘(1) SCHEDULE.— 15

‘‘(A) IN GENERAL.—The Administrator 16

shall inform the public regarding the schedule 17

for the completion of each safety assessment 18

and safety determination as soon as practicable 19

after designation as a high-priority substance 20

pursuant to section 4A. 21

‘‘(B) DIFFERING TIMES.—The Adminis-22

trator may allot different times for different 23

chemical substances in the schedules under this 24

paragraph, subject to the condition that all 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

14

•S 697 RS

schedules shall comply with the deadlines estab-1

lished under section 6. 2

‘‘(C) ANNUAL PLAN.—At the beginning of 3

each calendar year, the Administrator shall 4

identify the substances subject to safety assess-5

ments and safety determinations to be com-6

pleted that year. 7

‘‘(2) POLICIES AND PROCEDURES FOR SAFETY 8

ASSESSMENTS AND SAFETY DETERMINATIONS.— 9


shall establish, by rule, policies and procedures 11

regarding the manner in which the Adminis-12

trator shall carry out section 6. 13

‘‘(B) GOAL.—A goal of the policies and 14

procedures under this paragraph shall be to 15

make the basis of decisions of the Adminis-16

trator clear to the public. 17

‘‘(C) MINIMUM REQUIREMENTS.—At a 18

minimum, the policies and procedures under 19

this paragraph shall— 20

‘‘(i) describe— 21

‘‘(I) the manner in which the Ad-22

ministrator will identify informational 23

needs and seek that information from 24

the public; 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

15

•S 697 RS

‘‘(II) the information (including 1

draft safety assessments) that may be 2

submitted by interested individuals or 3

entities, including States; and 4

‘‘(III) the criteria by which that 5

information will be evaluated; 6

‘‘(ii) require the Administrator— 7

‘‘(I)(aa) to define the scope of 8

the safety assessment and safety de-9

termination to be conducted under 10

section 6, including the hazards, expo-11

sures, conditions of use, and poten-12

tially exposed and susceptible popu-13

lations that the Administrator expects 14

to consider in a safety assessment; 15

‘‘(bb) to explain the basis for the 16

scope of the safety assessment and 17

safety determination; and 18

‘‘(cc) to accept comments regard-19

ing the scope of the safety assessment 20

and safety determination; and 21

‘‘(II)(aa) to identify the items de-22

scribed in subclause (I) that the Ad-23

ministrator has considered in the final 24

safety assessment; and 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

16

•S 697 RS


consideration of those items; 2

‘‘(iii) describe the manner in which 3

aggregate exposures, or significant subsets 4

of exposures, to a chemical substance 5

under the conditions of use will be consid-6

ered, and explain the basis for that consid-7

eration in the final safety assessment; 8

‘‘(iv) require that each safety assess-9

ment and safety determination shall in-10

clude— 11

‘‘(I) a description of the weight 12

of the scientific evidence of risk; and 13

‘‘(II) a summary of the informa-14

tion regarding the impact on health 15

and the environment of the chemical 16

substance that was used to make the 17

assessment or determination, includ-18

ing, as available, mechanistic, animal 19

toxicity, and epidemiology studies; 20

‘‘(v) establish a timely and trans-21

parent process for evaluating whether new 22

information submitted or obtained after 23

the date of a final safety assessment or 24

safety determination warrants reconsider-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

17

•S 697 RS

ation of the safety assessment or safety de-1

termination; and 2

‘‘(vi) when relevant information is 3

provided or otherwise made available to the 4

Administrator, shall consider the extent of 5

Federal regulation under other Federal 6

laws. 7

‘‘(D) GUIDANCE.— 8

‘‘(i) IN GENERAL.—Not later than 1 9

year after the date of enactment of the 10

Frank R. Lautenberg Chemical Safety for 11

the 21st Century Act, the Administrator 12

shall develop guidance to assist interested 13

persons in developing draft safety assess-14

ments and other information for submis-15

sion to the Administrator, which may be 16

considered at the discretion of the Admin-17

istrator. 18

‘‘(ii) REQUIREMENT.—The guidance 19

shall, at a minimum, address the quality of 20

the information submitted and the process 21

to be followed in developing a draft assess-22

ment for consideration by the Adminis-23

trator. 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

18

•S 697 RS

‘‘(3) ARTICLES.—If the Administrator intends 1

to prohibit or otherwise restrict an article on the 2

basis of a chemical substance contained in that arti-3

cle, the Administrator shall have evidence of signifi-4

cant exposure to the chemical substance from such 5

article. 6

‘‘(i) PUBLICLY AVAILABLE INFORMATION.—Subject 7

to section 14, the Administrator shall— 8

‘‘(1) make publicly available a nontechnical 9

summary, and the final version, of each safety as-10

sessment and safety determination; 11

‘‘(2) provide public notice and an opportunity 12

for comment on each proposed safety assessment 13


‘‘(3) make public in a final safety assessment 15

and safety determination— 16

‘‘(A) the list of studies considered by the 17

Administrator in carrying out the safety assess-18

ment or safety determination; and 19

‘‘(B) the list of policies, procedures, and 20

guidance that were followed in carrying out the 21

safety assessment or safety determination. 22

‘‘(j) CONSULTATION WITH SCIENCE ADVISORY COM-23

MITTEE ON CHEMICALS.— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

19

•S 697 RS

‘‘(1) ESTABLISHMENT.—Not later than 1 year 1

after the date of enactment of this section, the Ad-2

ministrator shall establish an advisory committee, to 3

be known as the ‘Science Advisory Committee on 4

Chemicals’ (referred to in this subsection as the 5

‘Committee’). 6

‘‘(2) PURPOSE.—The purpose of the Committee 7

shall be to provide independent advice and expert 8

consultation, on the request of the Administrator, 9

with respect to the scientific and technical aspects of 10

issues relating to the implementation of this title. 11

‘‘(3) COMPOSITION.—The Committee shall be 12

composed of representatives of such science, govern-13

ment, labor, public health, public interest, animal 14

protection, industry, and other groups as the Admin-15

istrator determines to be advisable, including, at a 16

minimum, representatives that have specific sci-17

entific expertise in the relationship of chemical expo-18

sures to women, children, and other potentially ex-19

posed or susceptible populations. 20

‘‘(4) SCHEDULE.—The Administrator shall con-21

vene the Committee in accordance with such sched-22

ule as the Administrator determines to be appro-23

priate, but not less frequently than once every 2 24

years. 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

20

•S 697 RS

‘‘(5) RELATIONSHIP TO OTHER LAW.—All pro-1

ceedings and meetings of the Committee shall be 2

subject to the Federal Advisory Committee Act (5 3

U.S.C. App.).’’. 4

SEC. 5. TESTING OF CHEMICAL SUBSTANCES OR MIXTURES. 5

(a) IN GENERAL.—Section 4 of the Toxic Substances 6

Control Act (15 U.S.C. 2603) is amended— 7

(1) by striking subsections (a), (b), (c), (d), and 8

(g); 9

(2) by redesignating subsections (e) and (f) as 10

subsections (f) and (g), respectively; 11

(3) in subsection (f) (as so redesignated)— 12

(A) by striking ‘‘rule’’ each place it ap-13

pears and inserting ‘‘rule, testing consent 14

agreement, or order’’; 15

(B) by striking ‘‘under subsection (a)’’ 16

each place it appears and inserting ‘‘under this 17

subsection’’; and 18

(C) in paragraph (1)(B), in the last sen-19

tence, by striking ‘‘rulemaking’’; 20

(4) in subsection (g) (as so redesignated)— 21

(A) in the first sentence, by striking ‘‘from 22

cancer, gene mutations, or birth defects’’; and 23

(B) by striking the last sentence; and 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

21

•S 697 RS

(5) by inserting before subsection (f) (as so re-1


‘‘(a) DEVELOPMENT OF NEW INFORMATION ON 3

CHEMICAL SUBSTANCES AND MIXTURES.— 4

‘‘(1) IN GENERAL.—The Administrator may re-5

quire the development of new information relating to 6

a chemical substance or mixture in accordance with 7

this section if the Administrator determines that the 8

information is necessary— 9

‘‘(A) to review a notice under section 5(d) 10

or to perform a safety assessment or safety de-11

termination under section 6; 12

‘‘(B) to implement a requirement imposed 13

in a consent agreement or order issued under 14

section 5(d)(4) or under a rule promulgated 15

under section 6(d)(3); 16

‘‘(C) pursuant to section 12(a)(4); or 17

‘‘(D) at the request of the implementing 18

authority under another Federal law, to meet 19

the regulatory testing needs of that authority. 20

‘‘(2) LIMITED TESTING FOR PRIORITIZATION 21

PURPOSES.— 22


subparagraph (B), the Administrator may re-24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

22

•S 697 RS

quire the development of new information for 1

the purposes of section 4A. 2

‘‘(B) PROHIBITION.—Testing required 3

under subparagraph (A) shall not be required 4

for the purpose of establishing or implementing 5

a minimum information requirement. 6

‘‘(C) LIMITATION.—The Administrator 7

may require the development of new informa-8

tion pursuant to subparagraph (A) only if the 9

Administrator determines that additional infor-10

mation is necessary to establish the priority of 11

a chemical substance. 12

‘‘(3) FORM.—Subject to section 3A(h), the Ad-13

ministrator may require the development of informa-14

tion described in paragraph (1) or (2) by— 15

‘‘(A) promulgating a rule; 16

‘‘(B) entering into a testing consent agree-17

ment; or 18

‘‘(C) issuing an order. 19

‘‘(4) CONTENTS.— 20

‘‘(A) IN GENERAL.—A rule, testing con-21

sent agreement, or order issued under this sub-22

section shall include— 23


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

23

•S 697 RS

‘‘(i) identification of the chemical sub-1

stance or mixture for which testing is re-2

quired; 3

‘‘(ii) identification of the persons re-4

quired to conduct the testing; 5

‘‘(iii) test protocols and methodologies 6

for the development of test data and infor-7

mation for the chemical substance or mix-8

ture, including specific reference to reliable 9

nonanimal test procedures; and 10

‘‘(iv) specification of the period within 11

which individuals and entities required to 12

conduct the testing shall submit to the Ad-13

ministrator the information developed in 14

accordance with the procedures described 15

in clause (iii). 16

‘‘(B) CONSIDERATIONS.—In determining 17

the procedures and period to be required under 18

subparagraph (A), the Administrator shall take 19

into consideration— 20

‘‘(i) the relative costs of the various 21

test protocols and methodologies that may 22

be required; and 23


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

24

•S 697 RS

‘‘(ii) the reasonably foreseeable avail-1

ability of facilities and personnel required 2

to perform the testing. 3

‘‘(b) STATEMENT OF NEED.— 4

‘‘(1) IN GENERAL.—In promulgating a rule, en-5

tering into a testing consent agreement, or issuing 6

an order for the development of additional informa-7

tion (including information on exposure or exposure 8

potential) pursuant to this section, the Adminis-9

trator shall— 10

‘‘(A) identify the need intended to be met 11

by the rule, agreement, or order; 12

‘‘(B) explain why information reasonably 13

available to the Administrator at that time is 14

inadequate to meet that need, including a ref-15

erence, as appropriate, to the information iden-16

tified in paragraph (2)(B); and 17

‘‘(C) explain the basis for any decision that 18

requires the use of vertebrate animals. 19

‘‘(2) EXPLANATION IN CASE OF ORDER.— 20

‘‘(A) IN GENERAL.—If the Administrator 21

issues an order under this section, the Adminis-22

trator shall issue a statement providing a jus-23

tification for why issuance of an order is war-24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

25

•S 697 RS

ranted instead of promulgating a rule or enter-1

ing into a testing consent agreement. 2

‘‘(B) CONTENTS.—A statement described 3

in subparagraph (A) shall contain a description 4

of— 5

‘‘(i) information that is readily acces-6

sible to the Administrator, including infor-7

mation submitted under any other provi-8

sion of law; 9

‘‘(ii) the extent to which the Adminis-10

trator has obtained or attempted to obtain 11

the information through voluntary submis-12

sions; and 13

‘‘(iii) any information relied on in 14

safety assessments for other chemical sub-15

stances relevant to the chemical substances 16

that would be the subject of the order. 17

‘‘(c) REDUCTION OF TESTING ON VERTEBRATES.— 18

‘‘(1) IN GENERAL.—The Administrator shall 19

minimize, to the extent practicable, the use of 20

vertebrate animals in testing of chemical substances 21

or mixtures, by— 22

‘‘(A) encouraging and facilitating— 23

‘‘(i) the use of integrated and tiered 24

testing and assessment strategies; 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

26

•S 697 RS

‘‘(ii) the use of best available science 1

in existence on the date on which the test 2

is conducted; 3

‘‘(iii) the use of test methods that 4

eliminate or reduce the use of animals 5

while providing information of high sci-6

entific quality; 7

‘‘(iv) the grouping of 2 or more chem-8

ical substances into scientifically appro-9

priate categories in cases in which testing 10

of a chemical substance would provide reli-11

able and useful information on other chem-12

ical substances in the category; 13

‘‘(v) the formation of industry con-14

sortia to jointly conduct testing to avoid 15

unnecessary duplication of tests; and 16

‘‘(vi) the submission of information 17

from— 18

‘‘(I) animal-based studies; and 19

‘‘(II) emerging methods and 20

models; and 21

‘‘(B) funding research and validation stud-22

ies to reduce, refine, and replace the use of ani-23

mal tests in accordance with this subsection. 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

27

•S 697 RS

‘‘(2) IMPLEMENTATION OF ALTERNATIVE TEST-1

ING METHODS.—To promote the development and 2

timely incorporation of new testing methods that are 3

not based on vertebrate animals, the Administrator 4

shall— 5

‘‘(A) after providing an opportunity for 6

public comment, develop a strategic plan to pro-7

mote the development and implementation of al-8

ternative test methods and testing strategies to 9

generate information under this title that can 10

reduce, refine, or replace the use of vertebrate 11

animals, including toxicity pathway-based risk 12

assessment, in vitro studies, systems biology, 13

computational toxicology, bioinformatics, and 14

high-throughput screening; 15

‘‘(B) as practicable, ensure that the stra-16

tegic plan developed under subparagraph (A) is 17

reflected in the development of requirements for 18

testing under this section; 19

‘‘(C) beginning on the date that is 5 years 20

after the date of enactment of the Frank R. 21

Lautenberg Chemical Safety for the 21st Cen-22

tury Act and every 5 years thereafter, submit to 23

Congress a report that describes the progress 24

made in implementing this subsection and goals 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

28

•S 697 RS

for future alternative test methods implementa-1

tion; and 2

‘‘(D) fund and carry out research, develop-3

ment, performance assessment, and 4

translational studies to accelerate the develop-5

ment of test methods and testing strategies that 6

reduce, refine, or replace the use of vertebrate 7

animals in any testing under this title. 8

‘‘(3) CRITERIA FOR ADAPTING OR WAIVING ANI-9

MAL TESTING REQUIREMENTS.—On request from a 10

manufacturer or processor that is required to con-11

duct testing of a chemical substance or mixture on 12

vertebrate animals under this section, the Adminis-13

trator may adapt or waive the requirement, if the 14

Administrator determines that— 15

‘‘(A) there is sufficient evidence from sev-16

eral independent sources of information to sup-17

port a conclusion that a chemical substance or 18

mixture has, or does not have, a particular 19

property if the information from each individual 20

source alone is insufficient to support the con-21

clusion; 22

‘‘(B) as a result of 1 or more physical or 23

chemical properties of the chemical substance 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

29

•S 697 RS

or mixture or other toxicokinetic consider-1

ations— 2

‘‘(i) the substance cannot be absorbed; 3

or 4

‘‘(ii) testing for a specific endpoint is 5

technically not practicable to conduct; or 6

‘‘(C) a chemical substance or mixture can-7

not be tested in vertebrate animals at con-8

centrations that do not result in significant 9

pain or distress, because of physical or chemical 10

properties of the chemical substance or mixture, 11

such as a potential to cause severe corrosion or 12

severe irritation to the tissues of the animal. 13

‘‘(d) TESTING REQUIREMENTS.— 14


quire the development of information by— 16

‘‘(A) manufacturers and processors of the 17

chemical substance or mixture; and 18

‘‘(B) persons that begin to manufacture or 19

process the chemical substance or mixture— 20

‘‘(i) after the effective date of the 21

rule, testing consent agreement, or order; 22

but 23

‘‘(ii) subject to paragraph (3), before 24

the period ending on the date that is 180 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

30

•S 697 RS

days after the end of the period described 1

in this section. 2

‘‘(2) DESIGNATION.—The Administrator may 3

permit 2 or more persons identified in subparagraph 4

(A) or (B) of paragraph (1) to designate 1 of the 5

persons or a qualified third party— 6

‘‘(A) to develop the information; and 7

‘‘(B) to submit the information on behalf 8

of the persons making the designation. 9

‘‘(3) EXEMPTIONS.— 10

‘‘(A) IN GENERAL.—A person otherwise 11

subject to a rule, testing consent agreement, or 12

order under this section may submit to the Ad-13

ministrator an application for an exemption on 14

the basis that the information is being devel-15

oped by a person designated under paragraph 16

(2). 17

‘‘(B) FAIR AND EQUITABLE REIMBURSE-18

MENT TO DESIGNEE.— 19

‘‘(i) IN GENERAL.—If the Adminis-20

trator accepts an application submitted 21

under subparagraph (A), the Adminis-22

trator shall direct the applicant to provide 23

to the person designated under paragraph 24

(2) fair and equitable reimbursement, as 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

31

•S 697 RS

agreed to between the applicant and the 1

designee. 2

‘‘(ii) ARBITRATION.—If the applicant 3

and a person designated under paragraph 4

(2) cannot reach agreement on the amount 5

of fair and equitable reimbursement, the 6

amount shall be determined by arbitration. 7

‘‘(C) TERMINATION.—If, after granting an 8

exemption under this paragraph, the Adminis-9

trator determines that a person covered by the 10

exemption has failed to comply with the rule, 11

testing consent agreement, or order, the Admin-12

istrator shall— 13

‘‘(i) by order, terminate the exemp-14

tion; and 15

‘‘(ii) notify in writing each person 16

that received an exemption of the require-17

ments with respect to which the exemption 18

was granted. 19

‘‘(e) TRANSPARENCY.—Subject to section 14, the Ad-20

ministrator shall make available to the public all testing 21

consent agreements and orders and all information sub-22

mitted under this section.’’. 23

(b) CONFORMING AMENDMENT.—Section 24

104(i)(5)(A) of the Comprehensive Environmental Re-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

32

•S 697 RS

sponse, Compensation, and Liability Act of 1980 (42 1

U.S.C. 9604(i)(5)(A)) is amended in the third sentence 2

by striking ‘‘section 4(e)’’ and inserting ‘‘section 4(f)’’. 3

SEC. 6. PRIORITIZATION SCREENING. 4



‘‘SEC. 4A. PRIORITIZATION SCREENING. 7

‘‘(a) ESTABLISHMENT AND LIST OF SUBSTANCES.— 8

‘‘(1) IN GENERAL.—Not later than 1 year after 9

the date of enactment of this section, the Adminis-10

trator shall establish, by rule, a risk-based screening 11

process and explicit criteria for identifying existing 12

chemical substances that are— 13

‘‘(A) a high priority for a safety assess-14

ment and safety determination under section 6 15

(referred to in this Act as ‘high-priority sub-16

stances’); and 17

‘‘(B) a low priority for a safety assessment 18

and safety determination (referred to in this 19

Act as ‘low-priority substances’). 20

‘‘(2) INITIAL LIST OF HIGH- AND LOW-PRIORITY 21

SUBSTANCES.— 22

‘‘(A) IN GENERAL.—Before the date of 23

promulgation of the rule under paragraph (1) 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

33

•S 697 RS

and not later than 180 days after the date of 1

enactment of this section, the Administrator— 2

‘‘(i) shall take into consideration and 3

publish an initial list of high-priority sub-4

stances and low-priority substances; and 5

‘‘(ii) pursuant to section 6(b), may 6

initiate or continue safety assessments and 7

safety determinations for those high-pri-8

ority substances. 9

‘‘(B) REQUIREMENTS.— 10

‘‘(i) IN GENERAL.—The initial list of 11

chemical substances shall contain at least 12

10 high-priority substances, at least 5 of 13

which are drawn from the list of chemical 14

substances identified by the Administrator 15

in the October, 2014 TSCA Work Plan 16

and subsequent updates, and at least 10 17

low-priority substances. 18

‘‘(ii) SUBSEQUENTLY IDENTIFIED 19

SUBSTANCES.—Insofar as possible, at least 20

50 percent of all substances subsequently 21

identified by the Administrator as high-pri-22

ority substances shall be drawn from the 23

list of chemical substances identified by the 24

Administrator in the October, 2014 TSCA 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

34

•S 697 RS

Work Plan and subsequent updates, until 1

all Work Plan chemicals have been des-2

ignated under this subsection. 3

‘‘(C) ADDITIONAL CHEMICAL REVIEWS.— 4

The Administrator shall— 5

‘‘(i) 3 years after the date of enact-6

ment of the Frank R. Lautenberg Chem-7

ical Safety for the 21st Century Act, add 8

additional high-priority substances suffi-9

cient to ensure that at least a total of 20 10

high-priority substances have undergone or 11

are undergoing the process established in 12

section 6(a), and additional low-priority 13

substances sufficient to ensure that at 14

least a total of 20 low-priority substances 15

have been designated; and 16

‘‘(ii) as soon as practicable and not 17

later than 5 years after the date of enact-18


ical Safety for the 21st Century Act, add 20

additional high-priority substances suffi-21

cient to ensure that at least a total of 25 22

high-priority substances have undergone or 23

are undergoing the process established in 24

section 6(a), and additional low-priority 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

35

•S 697 RS

substances sufficient to ensure that at 1

least a total of 25 low-priority substances 2

have been designated. 3

‘‘(3) IMPLEMENTATION.— 4

‘‘(A) CONSIDERATION OF ACTIVE AND IN-5

ACTIVE SUBSTANCES.— 6

‘‘(i) ACTIVE SUBSTANCES.—In car-7

rying out paragraph (1), the Administrator 8

shall take into consideration active sub-9

stances, as determined under section 8, 10

which may include chemical substances on 11

the interim list of active substances estab-12

lished under that section. 13

‘‘(ii) INACTIVE SUBSTANCES.—In car-14


may take into consideration inactive sub-16


that the Administrator determines— 18

‘‘(I)(aa) have not been subject to 19

a regulatory or other enforceable ac-20

tion by the Administrator to ban or 21

phase out the substances; and 22

‘‘(bb) have the potential for high 23

hazard and widespread exposure; or 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

36

•S 697 RS

‘‘(II)(aa) have been subject to a 1

regulatory or other enforceable action 2

by the Administrator to ban or phase 3

out the substances; and 4

‘‘(bb) with respect to which there 5

exists the potential for residual high 6

hazards or widespread exposures not 7

otherwise addressed by the regulatory 8

or other action. 9

‘‘(iii) REPOPULATION.— 10

‘‘(I) IN GENERAL.—On the com-11

pletion of a safety determination 12

under section 6 for a chemical sub-13

stance, the Administrator shall re-14

move the chemical substance from the 15

list of high-priority substances estab-16

lished under this subsection. 17

‘‘(II) ADDITIONS.—The Adminis-18

trator shall add at least 1 chemical 19

substance to the list of high-priority 20

substances for each chemical sub-21

stance removed from the list of high- 22

priority substances established under 23

this subsection, until a safety assess-24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

37

•S 697 RS

ment and safety determination is com-1

pleted for all high-priority substances. 2

‘‘(III) LOW-PRIORITY SUB-3

STANCES.—If a low-priority substance 4

is subsequently designated as a high- 5

priority substance, the Administrator 6

shall remove that substance from the 7

list of low-priority substances. 8

‘‘(B) TIMELY COMPLETION OF 9

PRIORITIZATION SCREENING PROCESS.— 10

‘‘(i) IN GENERAL.—The Administrator 11

shall— 12

‘‘(I) not later than 180 days 13

after the effective date of the final 14

rule under paragraph (1), begin the 15

prioritization screening process; and 16

‘‘(II) make every effort to com-17

plete the designation of all active sub-18

stances as high-priority substances or 19

low-priority substances in a timely 20

manner. 21

‘‘(ii) DECISIONS ON SUBSTANCES SUB-22

JECT TO TESTING FOR PRIORITIZATION 23

PURPOSES.—Not later than 90 days after 24

the date of receipt of information regard-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

38

•S 697 RS

ing a chemical substance complying with a 1

rule, testing consent agreement, or order 2

issued under section 4(a)(2), the Adminis-3

trator shall designate the chemical sub-4

stance as a high-priority substance or low- 5

priority substance. 6

‘‘(iii) CONSIDERATION.— 7

‘‘(I) IN GENERAL.—The Admin-8

istrator shall screen substances and 9

designate high-priority substances 10

taking into consideration the ability of 11

the Administrator to schedule and 12

complete safety assessments and safe-13

ty determinations under section 6 in a 14

timely manner. 15

‘‘(II) ANNUAL GOAL.—The Ad-16

ministrator shall publish an annual 17

goal for the number of chemical sub-18

stances to be subject to the 19

prioritization screening process. 20

‘‘(C) SCREENING OF CATEGORIES OF SUB-21

STANCES.—The Administrator may screen cat-22

egories of chemical substances to ensure an effi-23

cient prioritization screening process to allow 24

for timely and adequate designations of high- 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

39

•S 697 RS

priority substances and low-priority substances 1

and safety assessments and safety determina-2

tions for high-priority substances. 3

‘‘(D) PUBLICATION OF LIST OF CHEMICAL 4

SUBSTANCES.—Not less frequently than once 5

each year, the Administrator shall publish a list 6

of chemical substances that— 7

‘‘(i) are being considered in the 8

prioritization screening process and the 9

status of the chemical substances in the 10

prioritization process, including those 11

chemical substances for which 12

prioritization decisions have been deferred; 13

and 14

‘‘(ii) are designated as high-priority 15

substances or low-priority substances, in-16

cluding the bases for such designations. 17

‘‘(4) CRITERIA.—The criteria described in para-18

graph (1) shall account for— 19

‘‘(A) the recommendation of the Governor 20

of a State or a State agency with responsibility 21

for protecting health or the environment from 22

chemical substances appropriate for 23

prioritization screening; 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

40

•S 697 RS

‘‘(B) the hazard and exposure potential of 1

the chemical substance (or category of sub-2

stances), including specific scientific classifica-3

tions and designations by authoritative govern-4

mental entities; 5

‘‘(C) the conditions of use or significant 6

changes in the conditions of use of the chemical 7

substance; 8

‘‘(D) evidence and indicators of exposure 9

potential to humans or the environment from 10

the chemical substance, including potentially ex-11

posed or susceptible populations; 12

‘‘(E) the volume of a chemical substance 13

manufactured or processed; 14

‘‘(F) whether the volume of a chemical 15

substance as reported under a rule promulgated 16

pursuant to section 8(a) has significantly in-17

creased or decreased during the period begin-18

ning on the date of a previous report or the 19

date on which a notice has been submitted 20

under section 5(b) for that chemical substance; 21

‘‘(G) the availability of information regard-22

ing potential hazards and exposures required 23

for conducting a safety assessment or safety de-24

termination, with limited availability of relevant 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

41

•S 697 RS

information to be a sufficient basis for desig-1

nating a chemical substance as a high-priority 2

substance, subject to the condition that limited 3

availability shall not require designation as a 4

high-priority substance; and 5

‘‘(H) the extent of Federal or State regula-6

tion of the chemical substance or the extent of 7

the impact of State regulation of the chemical 8

substance on the United States, with existing 9

Federal or State regulation of any uses evalu-10

ated in the prioritization screening process as a 11

factor in designating a chemical substance to be 12

a low-priority substance. 13

‘‘(b) PRIORITIZATION SCREENING PROCESS AND DE-14

CISIONS.— 15

‘‘(1) IN GENERAL.—The prioritization screening 16

process developed under subsection (a) shall include 17

a requirement that the Administrator shall— 18

‘‘(A) identify the chemical substances 19

being considered for prioritization; 20

‘‘(B) request interested persons to supply 21

information regarding the chemical substances 22

being considered; 23

‘‘(C) apply the criteria identified in sub-24

section (a)(4); and 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

42

•S 697 RS

‘‘(D) subject to paragraph (5) and using 1

the information available to the Administrator 2

at the time of the decision, identify a chemical 3

substance as a high-priority substance or a low- 4

priority substance. 5

‘‘(2) INTEGRATION OF INFORMATION.—The 6

prioritization screening decision regarding a chem-7

ical substance shall integrate any hazard and expo-8

sure information relating to the chemical substance 9

that is available to the Administrator. 10

‘‘(3) IDENTIFICATION OF HIGH-PRIORITY SUB-11

STANCES.—The Administrator— 12

‘‘(A) shall identify as a high-priority sub-13

stance a chemical substance that, relative to 14

other chemical substances, the Administrator 15

determines has the potential for high hazard 16

and widespread exposure; 17

‘‘(B) may identify as a high-priority sub-18


other chemical substances, the Administrator 20

determines has the potential for high hazard or 21

widespread exposure; and 22

‘‘(C) may identify as a high-priority sub-23

stance an inactive substance, as determined 24

under subsection (a)(3)(A)(ii) and section 8(b), 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

43

•S 697 RS

that the Administrator determines warrants a 1

safety assessment and safety determination 2

under section 6. 3

‘‘(4) IDENTIFICATION OF LOW-PRIORITY SUB-4

STANCES.—The Administrator shall identify as a 5

low-priority substance a chemical substance that the 6

Administrator concludes has information sufficient 7

to establish that the chemical substance is likely to 8

meet the applicable safety standard. 9

‘‘(5) DEFERRING A DECISION.—If the Adminis-10

trator determines that additional information is re-11

quired to establish the priority of a chemical sub-12

stance under this section, the Administrator may 13

defer the prioritization screening decision for a rea-14

sonable period— 15

‘‘(A) to allow for the submission of addi-16

tional information by an interested person and 17

for the Administrator to evaluate the additional 18

information; or 19

‘‘(B) to require the development of infor-20

mation pursuant to a rule, testing consent 21

agreement, or order issued under section 22

4(a)(2). 23

‘‘(6) DEADLINES FOR SUBMISSION OF INFOR-24

MATION.—If the Administrator requests the develop-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

44

•S 697 RS

ment or submission of information under this sec-1

tion, the Administrator shall establish a deadline for 2

submission of the information. 3

‘‘(7) NOTICE AND COMMENT.—The Adminis-4

trator shall— 5

‘‘(A) publish the proposed decisions made 6

under paragraphs (3), (4), and (5) and the 7

basis for the decisions; and 8

‘‘(B) provide an opportunity for public 9

comment. 10

‘‘(8) REVISIONS OF PRIOR DESIGNATIONS.— 11

‘‘(A) IN GENERAL.—At any time, and at 12

the discretion of the Administrator, the Admin-13

istrator may revise the designation of a chem-14

ical substance as a high-priority substance or a 15

low-priority substance based on information 16

available to the Administrator after the date of 17

the determination under paragraph (3) or (4). 18

‘‘(B) LIMITED AVAILABILITY.—If limited 19

availability of relevant information was a basis 20

in the designation of a chemical substance as a 21

high-priority substance, the Administrator shall 22

reevaluate the prioritization screening of the 23

chemical substance on receiving the relevant in-24

formation. 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

45

•S 697 RS

‘‘(9) OTHER INFORMATION RELEVANT TO 1

PRIORITIZATION.— 2

‘‘(A) IN GENERAL.—If, after the date of 3

enactment of the Frank R. Lautenberg Chem-4

ical Safety for the 21st Century Act, a State 5

proposes an administrative action or enacts a 6

statute or takes an administrative action to pro-7

hibit or otherwise restrict the manufacturing, 8

processing, distribution in commerce, or use of 9

a chemical substance that the Administrator 10

has not as designated a high-priority substance, 11

the Governor or State agency with responsi-12

bility for implementing the statute or adminis-13

trative action shall notify the Administrator. 14

‘‘(B) REQUESTS FOR INFORMATION.—Fol-15

lowing receipt of a notification provided under 16

subparagraph (A), the Administrator may re-17

quest any available information from the Gov-18

ernor or the State agency with respect to— 19

‘‘(i) scientific evidence related to the 20

hazards, exposures and risks of the chem-21

ical substance under the conditions of use 22

which the statute or administrative action 23

is intended to address; 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

46

•S 697 RS

‘‘(ii) any State or local conditions 1

which warranted the statute or administra-2

tive action; 3

‘‘(iii) the statutory or administrative 4

authority on which the action is based; and 5

‘‘(iv) any other available information 6

relevant to the prohibition or other restric-7

tion, including information on any alter-8

natives considered and their hazards, expo-9

sures, and risks. 10

‘‘(C) PRIORITIZATION SCREENING.—The 11

Administrator shall conduct a prioritization 12

screening under this subsection for all sub-13

stances that— 14

‘‘(i) are the subject of notifications re-15

ceived under subparagraph (A); and 16

‘‘(ii) the Administrator determines— 17

‘‘(I) are likely to have significant 18

health or environmental impacts; 19

‘‘(II) are likely to have signifi-20

cant impact on interstate commerce; 21

or 22

‘‘(III) have been subject to a pro-23

hibition or other restriction under a 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

47

•S 697 RS

statute or administrative action in 2 1

or more States. 2

‘‘(D) AVAILABILITY TO PUBLIC.—Subject 3

to section 14 and any applicable State law re-4

garding the protection of confidential informa-5

tion provided to the State or to the Adminis-6

trator, the Administrator shall make informa-7

tion received from a Governor or State agency 8

under subparagraph (A) publicly available. 9

‘‘(E) EFFECT OF PARAGRAPH.—Nothing 10

in this paragraph shall preempt a State statute 11

or administrative action, require approval of a 12

State statute or administrative action, or apply 13

section 15 to a State. 14

‘‘(10) REVIEW.—Not less frequently than once 15

every 5 years after the date on which the process 16

under this subsection is established, the Adminis-17

trator shall— 18

‘‘(A) review the process on the basis of ex-19

perience and taking into consideration resources 20

available to efficiently and effectively screen and 21

prioritize chemical substances; and 22

‘‘(B) if necessary, modify the prioritization 23

screening process. 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

48

•S 697 RS

‘‘(11) EFFECT.—Subject to section 18, a des-1

ignation by the Administrator under this section 2

with respect to a chemical substance shall not af-3

fect— 4

‘‘(A) the manufacture, processing, distribu-5

tion in commerce, use, or disposal of the chem-6

ical substance; or 7

‘‘(B) the regulation of those activities. 8

‘‘(c) ADDITIONAL PRIORITIES FOR SAFETY ASSESS-9

MENTS AND DETERMINATIONS.— 10


process developed under subsection (a) shall— 12

‘‘(A) include a process by which a manu-13

facturer or processor of an active chemical sub-14

stance that has not been designated a high-pri-15

ority substance, or that has not been subject to 16

or is not in the process of a prioritization 17

screening by the Administrator, may request 18

that the Administrator designate the substance 19

for a safety assessment and safety determina-20

tion, subject to the payment of fees pursuant to 21

section 26(b)(3)(E); and 22

‘‘(B) provide guidance to submitters on the 23

information to be provided in such requests, 24

and specify the criteria the Administrator shall 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

49

•S 697 RS

use to determine whether or not to grant such 1

a request, which shall include whether the sub-2

stance is subject to restrictions imposed by stat-3

utes enacted or administrative actions taken by 4

1 or more States on the manufacture, proc-5

essing, distribution in commerce, or use of the 6

substance. 7

‘‘(2) PREFERENCE.—Subject to paragraph (3), 8

in deciding whether to grant requests under this 9

subsection the Administrator shall give a preference 10

to requests concerning substances for which the Ad-11

ministrator determines that restrictions imposed by 12

1 or more States have the potential to have a signifi-13

cant impact on interstate commerce or health or the 14

environment. 15

‘‘(3) LIMITATIONS.—In considering whether to 16

grant a request submitted under paragraph (1), the 17

Administrator shall ensure that— 18

‘‘(A) not more than 15 percent of the total 19

number of substances designated to undergo 20

safety assessments and safety determinations 21

under this section are substances designated 22

under the process and criteria pursuant to 23

paragraph (1); and 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

50

•S 697 RS

‘‘(B) the resources allocated to conducting 1

safety assessments and safety determinations 2

for additional priorities designated under this 3

subsection are proportionate to the number of 4

such substances relative to the total number of 5

substances designated to undergo safety assess-6

ments and safety determinations under this sec-7

tion. 8

‘‘(4) REQUIREMENTS.— 9

‘‘(A) IN GENERAL.—The public shall be 10

provided notice and an opportunity to comment 11

on requests submitted under this subsection. 12

‘‘(B) DECISION BY ADMINISTRATOR.—Not 13

later than 180 days after the date on which the 14

Administrator receives a request under this 15

subsection, the Administrator shall decide 16

whether or not to grant the request. 17

‘‘(C) ASSESSMENT AND DETERMINA-18

TION.—If the Administrator grants a request 19

under this subsection, the safety assessment 20


‘‘(i) shall be conducted in accordance 22

with the deadlines and other requirements 23

of sections 3A(i) and 6; and 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

51

•S 697 RS

‘‘(ii) shall not be expedited or other-1

wise subject to special treatment relative to 2

high-priority substances designated pursu-3

ant to subsection (b)(3) that are under-4

going safety assessments and safety deter-5

minations. 6

‘‘(5) EXCEPTIONS.—Requests granted under 7

this subsection shall not be subject to subsection 8

(a)(3)(A)(iii) or section 18(b).’’. 9

SEC. 7. NEW CHEMICALS AND SIGNIFICANT NEW USES. 10



(1) by striking the section designation and 13

heading and inserting the following: 14

‘‘SEC. 5. NEW CHEMICALS AND SIGNIFICANT NEW USES.’’; 15

(2) by striking subsection (b); 16

(3) by redesignating subsection (a) as sub-17

section (b); 18

(4) by redesignating subsection (i) as subsection 19

(a) and moving the subsection so as to appear at the 20

beginning of the section; 21

(5) in subsection (b) (as so redesignated)— 22

(A) in the subsection heading, by striking 23

‘‘IN GENERAL’’ and inserting ‘‘NOTICES’’; and 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

52

•S 697 RS

(B) in paragraph (1), in the matter fol-1

lowing subparagraph (B)— 2

(i) by striking ‘‘subsection (d)’’ and 3

inserting ‘‘subsection (b)’’; and 4

(ii) by striking ‘‘and such person com-5

plies with any applicable requirement of 6

subsection (b)’’; 7

(6) by redesignating subsections (c) and (d) as 8

subsection (d) and (c), respectively, and moving sub-9

section (c) (as so redesigned) so as appear after sub-10

section (b) (as redesignated by paragraph (3)); 11

(7) in subsection (c) (as so redesignated)— 12

(A) by striking paragraph (1) and insert-13

ing the following: 14

‘‘(1) IN GENERAL.—The notice required by sub-15

section (a) shall include, with respect to a chemical 16

substance— 17

‘‘(A) the information required by sections 18

720.45 and 720.50 of title 40, Code of Federal 19

Regulations (or successor regulations); and 20

‘‘(B) information regarding conditions of 21

use and reasonably anticipated exposures.’’; 22

(B) in paragraph (2)— 23


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

53

•S 697 RS

(i) in the matter preceding subpara-1

graph (A), by striking ‘‘or of data under 2


(ii) in subparagraph (A), by adding 4

‘‘and’’ after the semicolon at the end; 5

(iii) in subparagraph (B), by striking 6

‘‘; and’’ and inserting a period; and 7

(iv) by striking subparagraph (C); and 8

(C) in paragraph (3), by striking ‘‘sub-9

section (a) and for which the notification period 10

prescribed by subsection (a), (b), or (c)’’ and 11

inserting ‘‘subsection (b) and for which the no-12

tification period prescribed by subsection (b) or 13

(d)’’; 14

(8) by striking subsection (d) (as redesignated 15

by paragraph (6)) and inserting the following: 16

‘‘(d) REVIEW OF NOTICE.— 17

‘‘(1) INITIAL REVIEW.— 18

‘‘(A) IN GENERAL.—Subject to subpara-19

graph (B), not later than 90 days after the date 20

of receipt of a notice submitted under sub-21

section (b), the Administrator shall— 22

‘‘(i) conduct an initial review of the 23

notice; 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

54

•S 697 RS

‘‘(ii) as needed, develop a profile of 1

the relevant chemical substance and the 2

potential for exposure to humans and the 3

environment; and 4

‘‘(iii) make any necessary determina-5

tion under paragraph (3). 6

‘‘(B) EXTENSION.—Except as provided in 7

paragraph (5), the Administrator may extend 8

the period described in subparagraph (A) for 9

good cause for 1 or more periods, the total of 10

which shall be not more than 90 days. 11

‘‘(2) INFORMATION SOURCES.—In evaluating a 12

notice under paragraph (1), the Administrator shall 13

take into consideration— 14

‘‘(A) any relevant information identified in 15

subsection (c)(1); and 16

‘‘(B) any other relevant additional infor-17

mation available to the Administrator. 18

‘‘(3) DETERMINATIONS.—Before the end of the 19

applicable period for review under paragraph (1), 20

based on the information described in paragraph (2), 21

and subject to section 18(g), the Administrator shall 22

determine that— 23

‘‘(A) the relevant chemical substance or 24

significant new use is not likely to meet the 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

55

•S 697 RS

safety standard, in which case the Adminis-1

trator shall take appropriate action under para-2

graph (4); 3

‘‘(B) the relevant chemical substance or 4

significant new use is likely to meet the safety 5

standard, in which case the Administrator shall 6

allow the review period to expire without addi-7

tional restrictions; or 8

‘‘(C) additional information is necessary in 9

order to make a determination under subpara-10

graph (A) or (B), in which case the Adminis-11


graph (5). 13

‘‘(4) RESTRICTIONS.— 14

‘‘(A) DETERMINATION BY ADMINIS-15

TRATOR.— 16


trator makes a determination under sub-18

paragraph (A) or (C) of paragraph (3) 19

with respect to a notice submitted under 20

subsection (b)— 21

‘‘(I) the Administrator, before 22

the end of the applicable period for re-23

view under paragraph (1) and by con-24

sent agreement or order, as appro-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

56

•S 697 RS

priate, shall prohibit or otherwise re-1

strict the manufacture, processing, 2

use, distribution in commerce, or dis-3

posal (as applicable) of the chemical 4

substance, or of the chemical sub-5

stance for a significant new use, with-6

out compliance with the restrictions 7

specified in the consent agreement or 8

order that the Administrator deter-9

mines are sufficient to ensure that the 10

chemical substance or significant new 11

use is likely to meet the safety stand-12

ard; and 13

‘‘(II) no person may commence 14

manufacture of the chemical sub-15

stance, or manufacture or processing 16

of the chemical substance for a sig-17

nificant new use, except in compliance 18

with the restrictions specified in the 19

consent agreement or order. 20

‘‘(ii) LIKELY TO MEET STANDARD.—If 21

the Administrator makes a determination 22

under subparagraph (B) of paragraph (3) 23

with respect to a chemical substance or 24

significant new use for which a notice was 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

57

•S 697 RS

submitted under subsection (b), at the end 1

of the applicable period for review under 2

paragraph (1), the submitter of the notice 3

may commence manufacture for commer-4

cial purposes of the chemical substance or 5

manufacture or processing of the chemical 6

substance for a significant new use. 7

‘‘(B) REQUIREMENTS.—Not later than 90 8

days after issuing a consent agreement or order 9

under subparagraph (A), the Administrator 10

shall— 11

‘‘(i) take into consideration whether to 12

promulgate a rule pursuant to subsection 13

(b)(2) that identifies as a significant new 14

use any manufacturing, processing, use, 15

distribution in commerce, or disposal of 16

the chemical substance, or of the chemical 17

substance for a new use, that is not in 18

compliance with the restrictions imposed 19

by the consent agreement or order; and 20

‘‘(ii)(I) initiate a rulemaking described 21

in clause (i); or 22

‘‘(II) publish a statement describing 23

the reasons of the Administrator for not 24

initiating a rulemaking. 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

58

•S 697 RS

‘‘(C) INCLUSIONS.—A prohibition or other 1

restriction under subparagraph (A) may in-2

clude, as appropriate— 3

‘‘(i) subject to section 18(g), a re-4

quirement that a chemical substance shall 5

be marked with, or accompanied by, clear 6

and adequate minimum warnings and in-7

structions with respect to use, distribution 8

in commerce, or disposal, or any combina-9

tion of those activities, with the form and 10

content of the minimum warnings and in-11

structions to be prescribed by the Adminis-12

trator; 13

‘‘(ii) a requirement that manufactur-14

ers or processors of the chemical substance 15

shall— 16

‘‘(I) make and retain records of 17

the processes used to manufacture or 18

process, as applicable, the chemical 19

substance; or 20

‘‘(II) monitor or conduct such 21

additional tests as are reasonably nec-22

essary to address potential risks from 23

the manufacture, processing, distribu-24

tion in commerce, use, or disposal, as 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

59

•S 697 RS

applicable, of the chemical substance, 1

subject to section 4; 2

‘‘(iii) a restriction on the quantity of 3

the chemical substance that may be manu-4

factured, processed, or distributed in com-5

merce— 6

‘‘(I) in general; or 7

‘‘(II) for a particular use; 8

‘‘(iv) a prohibition or other restriction 9

of— 10

‘‘(I) the manufacture, processing, 11

or distribution in commerce of the 12

chemical substance for a significant 13

new use; 14

‘‘(II) any method of commercial 15

use of the chemical substance; or 16

‘‘(III) any method of disposal of 17

the chemical substance; or 18

‘‘(v) a prohibition or other restriction 19

on the manufacture, processing, or dis-20

tribution in commerce of the chemical sub-21

stance— 22


‘‘(II) for a particular use. 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

60

•S 697 RS

‘‘(D) WORKPLACE EXPOSURES.—The Ad-1

ministrator shall consult with the Assistant Sec-2

retary of Labor for Occupational Safety and 3

Health prior to adopting any prohibition or 4

other restriction under this subsection to ad-5

dress workplace exposures. 6

‘‘(E) DEFINITION OF REQUIREMENT.—For 7

purposes of this Act, the term ‘requirement’ as 8

used in this section does not displace common 9

law. 10

‘‘(5) ADDITIONAL INFORMATION.—If the Ad-11

ministrator determines under paragraph (3)(C) that 12

additional information is necessary to conduct a re-13

view under this subsection, the Administrator— 14

‘‘(A) shall provide an opportunity for the 15

submitter of the notice to submit the additional 16

information; 17

‘‘(B) may, by agreement with the sub-18

mitter, extend the review period for a reason-19

able time to allow the development and submis-20

sion of the additional information; 21

‘‘(C) may promulgate a rule, enter into a 22

testing consent agreement, or issue an order 23

under section 4 to require the development of 24

the information; and 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

61

•S 697 RS

‘‘(D) on receipt of information the Admin-1

istrator finds supports the determination under 2

paragraph (3), shall promptly make the deter-3

mination.’’; 4

(9) by striking subsections (e) through (g) and 5

inserting the following: 6

‘‘(e) NOTICE OF COMMENCEMENT.— 7

‘‘(1) IN GENERAL.—Not later than 30 days 8

after the date on which a manufacturer that has 9

submitted a notice under subsection (b) commences 10

nonexempt commercial manufacture of a chemical 11

substance, the manufacturer shall submit to the Ad-12

ministrator a notice of commencement that identi-13

fies— 14

‘‘(A) the name of the manufacturer; and 15

‘‘(B) the initial date of nonexempt com-16

mercial manufacture. 17

‘‘(2) WITHDRAWAL.—A manufacturer or proc-18

essor that has submitted a notice under subsection 19

(b), but that has not commenced nonexempt com-20

mercial manufacture or processing of the chemical 21

substance, may withdraw the notice. 22

‘‘(f) FURTHER EVALUATION.—The Administrator 23

may review a chemical substance under section 4A at any 24

time after the Administrator receives— 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

62

•S 697 RS

‘‘(1) a notice of commencement for a chemical 1

substance under subsection (c); or 2

‘‘(2) new information regarding the chemical 3

substance. 4

‘‘(g) TRANSPARENCY.—Subject to section 14, the Ad-5

ministrator shall make available to the public— 6

‘‘(1) all notices, determinations, consent agree-7

ments, rules, and orders of the Administrator; and 8

‘‘(2) all information submitted or issued under 9

this section.’’; and 10

(10) in subsection (h)— 11

(A) in paragraph (1), in the matter pre-12

ceding subparagraph (A), by striking ‘‘(a) or’’; 13

(B) by striking paragraph (2); 14

(C) by redesignating paragraphs (3) 15

through (6) as paragraphs (2) through (5), re-16

spectively; 17

(D) in paragraph (2) (as so redesignated), 18

in the matter preceding subparagraph (A), by 19

striking ‘‘subsections (a) and (b)’’ and inserting 20

‘‘subsection (b)’’; 21

(E) in paragraph (3) (as so redesig-22

nated)— 23

(i) in the first sentence, by striking 24

‘‘will not present an unreasonable risk of 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

63

•S 697 RS

injury to health or the environment’’ and 1

inserting ‘‘will meet the safety standard’’; 2

and 3

(ii) by striking the second sentence; 4

(F) in paragraph (4) (as so redesignated), 5

by striking ‘‘subsections (a) and (b)’’ and in-6

serting ‘‘subsection (b)’’; and 7

(G) in paragraph (5) (as so redesignated), 8

in the first sentence, by striking ‘‘paragraph (1) 9

or (5)’’ and inserting ‘‘paragraph (1) or (4)’’. 10

SEC. 8. SAFETY ASSESSMENTS AND SAFETY DETERMINA-11

TIONS. 12



(1) by striking the section designation and 15

heading and inserting the following: 16

‘‘SEC. 6. SAFETY ASSESSMENTS AND SAFETY DETERMINA-17

TIONS.’’; 18


subsections (g) and (h), respectively; 20

(3) by striking subsections (a) through (d) and 21


‘‘(a) IN GENERAL.—The Administrator— 23

‘‘(1) shall conduct a safety assessment and 24

make a safety determination of each high-priority 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

64

•S 697 RS

substance in accordance with subsections (b) and 1

(c); 2

‘‘(2) shall, as soon as practicable and not later 3

than 6 months after the date on which a chemical 4

substance is designated as a high-priority substance, 5

define the scope of the safety assessment and safety 6

determination to be conducted pursuant to this sec-7

tion, including the hazards, exposures, conditions of 8

use, and potentially exposed or susceptible popu-9

lations that the Administrator expects to consider; 10

‘‘(3) as appropriate based on the results of a 11

safety determination, shall establish restrictions pur-12

suant to subsection (d); 13

‘‘(4) shall complete a safety assessment and 14

safety determination not later than 3 years after the 15

date on which a chemical substance is designated as 16

a high-priority substance; 17

‘‘(5) shall promulgate a final rule pursuant to 18

subsection (d) by not later than 2 years after the 19

date on which the safety determination is completed; 20

and 21

‘‘(6) may extend any deadline under this sub-22

section for a reasonable period of time after an ade-23

quate public justification, subject to the condition 24

that the aggregate length of all extensions of dead-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

65

•S 697 RS

lines under paragraphs (4) and (5) and any deferral 1

under subsection (c)(2) does not exceed 2 years. 2

‘‘(b) PRIOR ACTIONS.— 3

‘‘(1) PRIOR-INITIATED ASSESSMENTS.— 4

‘‘(A) IN GENERAL.—Nothing in this Act 5

prevents the Administrator from initiating a 6

safety assessment or safety determination re-7

garding a chemical substance, or from con-8

tinuing or completing such a safety assessment 9

or safety determination that was initiated be-10

fore the date of enactment of the Frank R. 11


tury Act, prior to the effective date of the poli-13

cies and procedures required to be established 14

by the Administrator under section 3A or 4A. 15

‘‘(B) INTEGRATION OF PRIOR POLICIES 16

AND PROCEDURES.—As policies and procedures 17

under section 3A and 4A are established, to the 18

maximum extent practicable, the Administrator 19

shall integrate the policies and procedures into 20

ongoing safety assessments and safety deter-21

minations. 22

‘‘(2) ACTIONS COMPLETED PRIOR TO COMPLE-23

TION OF POLICIES AND PROCEDURES.—Nothing in 24

this Act requires the Administrator to revise or with-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

66

•S 697 RS

draw a completed safety assessment, safety deter-1

mination, or rule solely because the action was com-2

pleted prior to the completion of a policy or proce-3

dure established under section 3A or 4A, and the va-4

lidity of a completed assessment, determination, or 5

rule shall not be determined based on the content of 6

such a policy or procedure. 7

‘‘(c) SAFETY DETERMINATIONS.— 8

‘‘(1) IN GENERAL.—Based on a review of the 9

information available to the Administrator, including 10

draft safety assessments submitted by interested 11

persons, and subject to section 18, the Adminis-12

trator shall determine that— 13

‘‘(A) the relevant chemical substance meets 14

the safety standard; 15

‘‘(B) the relevant chemical substance does 16

not meet the safety standard, in which case the 17

Administrator shall, by rule under subsection 18

(d)— 19

‘‘(i) impose restrictions necessary to 20

ensure that the chemical substance meets 21

the safety standard under the conditions of 22

use; or 23

‘‘(ii) if the safety standard cannot be 24

met with the application of restrictions, 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

67

•S 697 RS

ban or phase out the chemical substance, 1

as appropriate; or 2





graph (2). 7

‘‘(2) ADDITIONAL INFORMATION.—If the Ad-8

ministrator determines that additional information is 9

necessary to make a safety assessment or safety de-10

termination for a high-priority substance, the Ad-11

ministrator— 12

‘‘(A) shall provide an opportunity for inter-13

ested persons to submit the additional informa-14

tion; 15

‘‘(B) may promulgate a rule, enter into a 16


under section 4 to require the development of 18

the information; 19

‘‘(C) may defer, for a reasonable period 20

consistent with the deadlines described in sub-21

section (a), a safety assessment and safety de-22

termination until after receipt of the informa-23

tion; and 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

68

•S 697 RS

‘‘(D) consistent with the deadlines de-1

scribed in subsection (a), on receipt of informa-2

tion the Administrator finds supports the safety 3

assessment and safety determination, shall 4

make a determination under paragraph (1). 5

‘‘(3) ESTABLISHMENT OF DEADLINE.—In re-6

questing the development or submission of informa-7

tion under this section, the Administrator shall es-8

tablish a deadline for the submission of the informa-9

tion. 10

‘‘(d) RULE.— 11

‘‘(1) IMPLEMENTATION.—If the Administrator 12

makes a determination under subsection (c)(1)(B) 13

with respect to a chemical substance, the Adminis-14

trator shall promulgate a rule establishing restric-15

tions necessary to ensure that the chemical sub-16

stance meets the safety standard. 17

‘‘(2) SCOPE.—The rule promulgated pursuant 18

to this subsection— 19

‘‘(A) may— 20

‘‘(i) apply to mixtures containing the 21

chemical substance, as appropriate; and 22

‘‘(ii) exempt replacement parts for ar-23

ticles manufactured prior to the applicable 24

compliance deadline; and 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

69

•S 697 RS

‘‘(B) shall include dates by which compli-1

ance is mandatory, which— 2

‘‘(i) shall be as soon as practicable; 3

and 4

‘‘(ii) as determined by the Adminis-5

trator, may vary for different affected per-6

sons. 7

‘‘(C) WORKPLACE EXPOSURES.—The Ad-8



Health before adopting any prohibition or other 11

restriction under this subsection to address 12

workplace exposures. 13

‘‘(D) DEFINITION OF REQUIREMENT.—For 14

the purposes of this Act, the term ‘requirement’ 15

as used in this section does not displace com-16

mon law. 17

‘‘(3) RESTRICTIONS.—A restriction under para-18

graph (1) may include, as appropriate— 19

‘‘(A) subject to section 18, a requirement 20

that a chemical substance shall be marked with, 21

or accompanied by, clear and adequate min-22

imum warnings and instructions with respect to 23

use, distribution in commerce, or disposal, or 24

any combination of those activities, with the 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

70

•S 697 RS

form and content of the minimum warnings and 1

instructions to be prescribed by the Adminis-2

trator; 3

‘‘(B) a requirement that manufacturers or 4

processors of the chemical substance shall— 5

‘‘(i) make and retain records of the 6

processes used to manufacture or process 7

the chemical substance; 8

‘‘(ii) describe and apply the relevant 9

quality control procedures followed in the 10

manufacturing or processing of the sub-11

stance; or 12

‘‘(iii) monitor or conduct tests that 13

are reasonably necessary to ensure compli-14

ance with the requirements of any rule 15

under this subsection; 16

‘‘(C) a restriction on the quantity of the 17

chemical substance that may be manufactured, 18

processed, or distributed in commerce; 19

‘‘(D) a requirement to ban or phase out, or 20

any other rule regarding, the manufacture, 21

processing, or distribution in commerce of the 22

chemical substance for— 23

‘‘(i) a particular use; 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

71

•S 697 RS

‘‘(ii) a particular use at a concentra-1

tion in excess of a level specified by the 2

Administrator; or 3

‘‘(iii) all uses; 4

‘‘(E) a restriction on the quantity of the 5


processed, or distributed in commerce for— 7

‘‘(i) a particular use; or 8


tion in excess of a level specified by the 10

Administrator; 11

‘‘(F) a requirement to ban, phase out, or 12

otherwise restrict any method of commercial 13

use of the chemical substance; 14

‘‘(G) a requirement to ban, phase out, or 15

otherwise restrict any method of disposal of the 16

chemical substance or any article containing the 17

chemical substance; and 18

‘‘(H) a requirement directing manufactur-19

ers or processors of the chemical substance to 20

give notice of the Administrator’s determination 21

under subsection (c)(1)(B) to distributors in 22

commerce of the chemical substance and, to the 23

extent reasonably ascertainable, to other per-24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

72

•S 697 RS

sons in the chain of commerce in possession of 1

the chemical substance. 2

‘‘(4) ANALYSIS FOR RULEMAKING.— 3

‘‘(A) CONSIDERATIONS.—In deciding 4

which restrictions to impose under paragraph 5

(3) as part of developing a rule under para-6

graph (1), the Administrator shall take into 7

consideration, to the extent practicable based on 8

reasonably available information, the quantifi-9

able and nonquantifiable costs and benefits of 10

the proposed regulatory action and of the 1 or 11

more primary alternative regulatory actions 12

considered by the Administrator. 13

‘‘(B) ALTERNATIVES.—As part of the 14

analysis, the Administrator shall review any 1 15

or more technically and economically feasible al-16

ternatives to the chemical substance that the 17

Administrator determines are relevant to the 18

rulemaking. 19

‘‘(C) PUBLIC AVAILABILITY.—In proposing 20

a rule under paragraph (1), the Administrator 21

shall make publicly available any analysis con-22

ducted under this paragraph. 23

‘‘(D) STATEMENT REQUIRED.—In making 24

final a rule under paragraph (1), the Adminis-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

73

•S 697 RS

trator shall include a statement describing how 1

the analysis considered under subparagraph (A) 2

was taken into account. 3



may exempt 1 or more uses of a chemical sub-6

stance from any restriction in a rule promul-7

gated under paragraph (1) if the Administrator 8

determines that— 9

‘‘(i) the rule cannot be complied with, 10

without— 11

‘‘(I) harming national security; 12

‘‘(II) causing significant disrup-13

tion in the national economy due to 14

the lack of availability of a chemical 15

substance; or 16

‘‘(III) interfering with a critical 17

or essential use for which no tech-18

nically and economically feasible safer 19

alternative is available, taking into 20

consideration hazard and exposure; or 21

‘‘(ii) the use of the chemical sub-22

stance, as compared to reasonably available 23

alternatives, provides a substantial benefit 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

74

•S 697 RS

to health, the environment, or public safe-1

ty. 2

‘‘(B) EXEMPTION ANALYSIS.—In pro-3

posing a rule under paragraph (1) that includes 4

an exemption under this paragraph, the Admin-5

istrator shall make publicly available any anal-6

ysis conducted under this paragraph to assess 7

the need for the exemption. 8

‘‘(C) STATEMENT REQUIRED.—In making 9

final a rule under paragraph (1) that includes 10


istrator shall include a statement describing 12

how the analysis considered under subpara-13

graph (B) was taken into account. 14

‘‘(D) ANALYSIS IN CASE OF BAN OR 15

PHASE-OUT.—In determining whether an ex-16

emption should be granted under this para-17

graph for a chemical substance for which a ban 18

or phase-out is proposed, the Administrator 19

shall take into consideration, to the extent prac-20

ticable based on reasonably available informa-21

tion, the quantifiable and nonquantifiable costs 22

and benefits of the 1 or more technically and 23

economically feasible alternatives to the chem-24

ical substance most likely to be used in place of 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

75

•S 697 RS

the chemical substance under the conditions of 1

use if the rule is promulgated. 2

‘‘(E) CONDITIONS.—As part of a rule pro-3

mulgated under paragraph (1), the Adminis-4

trator shall include conditions in any exemption 5

established under this paragraph, including rea-6

sonable recordkeeping, monitoring, and report-7

ing requirements, to the extent that the Admin-8

istrator determines the conditions are necessary 9

to protect health and the environment while 10

achieving the purposes of the exemption. 11

‘‘(F) DURATION.— 12


shall establish, as part of a rule under 14

paragraph (1) that contains an exemption 15

under this paragraph, a time limit on any 16

exemption for a time to be determined by 17

the Administrator as reasonable on a case- 18

by-case basis. 19

‘‘(ii) AUTHORITY OF ADMINIS-20

TRATOR.—The Administrator, by rule, may 21

extend, modify, or eliminate the exemption 22

if the Administrator determines, on the 23

basis of reasonably available information 24

and after adequate public justification, the 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

76

•S 697 RS

exemption warrants extension or is no 1

longer necessary. 2

‘‘(iii) CONSIDERATIONS.— 3

‘‘(I) IN GENERAL.—Subject to 4

subclause (II), the Administrator shall 5

issue exemptions and establish time 6

periods by considering factors deter-7

mined by the Administrator to be rel-8

evant to the goals of fostering innova-9

tion and the development of alter-10

natives that meet the safety standard. 11

‘‘(II) LIMITATION.—Any renewal 12

of an exemption in the case of a rule 13

requiring the ban or phase-out of a 14

chemical substance shall not exceed 5 15

years. 16

‘‘(e) IMMEDIATE EFFECT.—The Administrator may 17

declare a proposed rule under subsection (d) to be effective 18

on publication of the rule in the Federal Register and until 19

the effective date of final action taken respecting the rule, 20

if— 21

‘‘(1) the Administrator determines that— 22



ical substance or mixture subject to the pro-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

77

•S 697 RS

posed rule or any combination of those activi-1

ties is likely to result in an unreasonable risk 2

of serious or widespread harm to health or the 3

environment before the effective date; and 4

‘‘(B) making the proposed rule so effective 5

is necessary to protect the public interest; and 6

‘‘(2) in the case of a proposed rule to prohibit 7

the manufacture, processing, or distribution of a 8

chemical substance or mixture because of the risk 9

determined under paragraph (1)(A), a court has 10

granted relief in an action under section 7 with re-11

spect to that risk associated with the chemical sub-12

stance or mixture. 13

‘‘(f) FINAL AGENCY ACTION.—Under this section 14

and subject to section 18— 15

‘‘(1) a safety determination, and the associated 16

safety assessment, for a chemical substance that the 17

Administrator determines under subsection (c) meets 18

the safety standard, shall be considered to be a final 19

agency action, effective beginning on the date of 20

issuance of the final safety determination; and 21

‘‘(2) a final rule promulgated under subsection 22

(d), and the associated safety assessment and safety 23

determination that a chemical substance does not 24

meet the safety standard, shall be considered to be 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

78

•S 697 RS

a final agency action, effective beginning on the date 1

of promulgation of the final rule.’’; and 2

(4) in subsection (g) (as redesignated by para-3

graph (2))— 4

(A) by striking paragraph (4); and 5

(B) by redesignating paragraph (5) as 6

paragraph (4). 7

SEC. 9. IMMINENT HAZARDS. 8



(1) by striking subsection (a) and inserting the 11

following: 12

‘‘(a) CIVIL ACTIONS.— 13

‘‘(1) IN GENERAL.—The Administrator may 14

commence a civil action in an appropriate United 15

States district court for— 16

‘‘(A) seizure of an imminently hazardous 17

chemical substance or mixture or any article 18

containing the chemical substance or mixture; 19

‘‘(B) relief (as authorized by subsection 20

(b)) against any person that manufactures, 21

processes, distributes in commerce, uses, or dis-22

poses of, an imminently hazardous chemical 23

substance or mixture or any article containing 24

the chemical substance or mixture; or 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

79

•S 697 RS

‘‘(C) both seizure described in subpara-1

graph (A) and relief described in subparagraph 2

(B). 3

‘‘(2) RULE, ORDER, OR OTHER PROCEEDING.— 4

A civil action may be commenced under this para-5

graph, notwithstanding— 6

‘‘(A) the existence of— 7

‘‘(i) a decision by the Administrator 8

under section 4A, 5(d)(3), or 6(c)(1); or 9

‘‘(ii) a rule, testing consent agree-10

ment, or order under section 4, 5(d)(4), 11

6(d), or 6(h); or 12

‘‘(B) the pendency of any administrative or 13

judicial proceeding under any provision of this 14

Act.’’; 15

(2) in subsection (d), by striking ‘‘section 6(a)’’ 16

and inserting ‘‘section 6(c)’’; and 17

(3) in subsection (f), in the first sentence, by 18

striking ‘‘and unreasonable’’. 19

SEC. 10. INFORMATION COLLECTION AND REPORTING. 20



(1) in subsection (a)— 23

(A) in paragraph (3)(A)(ii)(I)— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

80

•S 697 RS

(i) by striking ‘‘5(b)(4)’’ and inserting 1

‘‘5’’; 2

(ii) by inserting ‘‘section 4 or’’ after 3

‘‘in effect under’’; and 4

(iii) by striking ‘‘5(e),’’ and inserting 5

‘‘5(d)(4);’’; and 6

(B) by adding at the end the following: 7

‘‘(4) RULES.— 8

‘‘(A) DEADLINE.— 9


years after the date of enactment of the 11



shall promulgate rules requiring the main-14

tenance of records and the reporting of in-15

formation known or reasonably ascertain-16

able by the person making the report, in-17

cluding rules requiring processors to report 18

information, so that the Administrator has 19

the information necessary to carry out sec-20

tions 4 and 6. 21

‘‘(ii) MODIFICATION OF PRIOR 22

RULES.—In carrying out this subpara-23

graph, the Administrator may modify, as 24

appropriate, rules promulgated before the 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

81

•S 697 RS

date of enactment of the Frank R. Lauten-1

berg Chemical Safety for the 21st Century 2

Act. 3

‘‘(B) CONTENTS.—The rules promulgated 4

pursuant to subparagraph (A)— 5

‘‘(i) may impose different reporting 6

and recordkeeping requirements on manu-7

facturers and processors; and 8

‘‘(ii) shall include the level of detail 9

necessary to be reported, including the 10

manner by which use and exposure infor-11

mation may be reported. 12

‘‘(C) ADMINISTRATION.—In implementing 13

the reporting and recordkeeping requirements 14

under this paragraph, the Administrator shall 15

take measures— 16

‘‘(i) to limit the potential for duplica-17

tion in reporting requirements; 18

‘‘(ii) to minimize the impact of the 19

rules on small manufacturers and proc-20

essors; and 21

‘‘(iii) to apply any reporting obliga-22

tions to those persons likely to have infor-23

mation relevant to the effective implemen-24

tation of this title. 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

82

•S 697 RS

‘‘(5) GUIDANCE.—The Administrator shall de-1

velop guidance relating to the information required 2

to be reported under the rules promulgated under 3

this subsection.’’; 4

(2) in subsection (b), by adding at the end the 5

following: 6

‘‘(3) NOMENCLATURE.— 7

‘‘(A) IN GENERAL.—In carrying out para-8

graph (1), the Administrator shall— 9

‘‘(i) maintain the use of Class 2 no-10

menclature in use on the date of enact-11


ical Safety for the 21st Century Act; 13

‘‘(ii) maintain the use of the Soap and 14

Detergent Association Nomenclature Sys-15

tem, published in March 1978 by the Ad-16

ministrator in section 1 of addendum III 17

of the document entitled ‘Candidate List of 18

Chemical Substances’, and further de-19

scribed in the appendix A of volume I of 20

the 1985 edition of the Toxic Substances 21

Control Act Substances Inventory (EPA 22

Document No. EPA–560/7–85–002a); and 23

‘‘(iii) treat all components of cat-24

egories that are considered to be statutory 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

83

•S 697 RS

mixtures under this Act as being included 1

on the list published under paragraph (1) 2

under the Chemical Abstracts Service 3

numbers for the respective categories, in-4

cluding, without limitation— 5

‘‘(I) cement, Portland, chemicals, 6

CAS No. 65997–15–1; 7

‘‘(II) cement, alumina, chemicals, 8

CAS No. 65997–16–2; 9

‘‘(III) glass, oxide, chemicals, 10

CAS No. 65997–17–3; 11

‘‘(IV) frits, chemicals, CAS No. 12

65997–18–4; 13

‘‘(V) steel manufacture, chemi-14

cals, CAS No. 65997–19–5; and 15

‘‘(VI) ceramic materials and 16

wares, chemicals, CAS No. 66402– 17

68–4. 18

‘‘(B) MULTIPLE NOMENCLATURE CONVEN-19

TIONS.— 20

‘‘(i) IN GENERAL.—If an existing 21

guidance allows for multiple nomenclature 22

conventions, the Administrator shall— 23

‘‘(I) maintain the nomenclature 24

conventions for substances; and 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

84

•S 697 RS

‘‘(II) develop new guidance 1

that— 2

‘‘(aa) establishes equivalency 3

between the nomenclature con-4

ventions for chemical substances 5

on the list published under para-6

graph (1); and 7

‘‘(bb) permits persons to 8

rely on the new guidance for pur-9

poses of determining whether a 10

chemical substance is on the list 11

published under paragraph (1). 12

‘‘(ii) MULTIPLE CAS NUMBERS.—For 13

any chemical substance appearing multiple 14

times on the list under different Chemical 15

Abstracts Service numbers, the Adminis-16

trator shall develop guidance recognizing 17

the multiple listings as a single chemical 18

substance. 19

‘‘(4) CHEMICAL SUBSTANCES IN COMMERCE.— 20

‘‘(A) RULES.— 21




the 21st Century Act, the Administrator, 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

85

•S 697 RS

by rule, shall require manufacturers and 1

processors to notify the Administrator, by 2

not later than 180 days after the date of 3

promulgation of the rule, of each chemical 4

substance on the list published under para-5

graph (1) that the manufacturer or proc-6

essor, as applicable, has manufactured or 7

processed for a nonexempt commercial pur-8

pose during the 10-year period ending on 9

the day before the date of enactment of the 10


the 21st Century Act. 12

‘‘(ii) ACTIVE SUBSTANCES.—The Ad-13

ministrator shall, pursuant to paragraph 14

(5)(A), designate chemical substances for 15

which notices are received under clause (i) 16

to be active substances on the list pub-17

lished under paragraph (1). 18

‘‘(B) CONFIDENTIAL CHEMICAL SUB-19

STANCES.—The rule promulgated by the Ad-20

ministrator pursuant to subparagraph (A) shall 21

require— 22

‘‘(i) the Administrator to maintain the 23

list under paragraph (1), which shall in-24

clude a confidential portion and a noncon-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

86

•S 697 RS

fidential portion consistent with this sec-1

tion and section 14; 2

‘‘(ii) a manufacturer or processor that 3

is submitting a notice pursuant to sub-4

paragraph (A) for a chemical substance on 5

the confidential portion of the list pub-6

lished under paragraph (1) to indicate in 7

the notice whether the manufacturer or 8

processor seeks to maintain any existing 9

claim for protection against disclosure of 10

the specific identity of the substance as 11

confidential pursuant to section 14; and 12

‘‘(iii) the substantiation of those 13

claims pursuant to section 14 and in ac-14

cordance with the review plan described in 15

subparagraph (C). 16

‘‘(C) REVIEW PLAN.—Not later than 1 17

year after the date on which the Administrator 18

compiles the initial list of active substances pur-19

suant to subparagraph (A), the Administrator 20

shall promulgate a rule that establishes a plan 21

to review all claims to protect the specific iden-22

tities of chemical substances on the confidential 23

portion of the list published under paragraph 24

(1) that are notified pursuant to subparagraph 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

87

•S 697 RS

(A) or identified as active substances under 1

subsection (f)(1). 2

‘‘(D) REQUIREMENTS OF REVIEW PLAN.— 3

The review plan under subparagraph (C) 4

shall— 5

‘‘(i) require, at the time requested by 6

the Administrator, all manufacturers or 7

processors asserting claims under subpara-8

graph (B) to substantiate the claim unless 9

the manufacturer or processor has sub-10

stantiated the claim in a submission made 11

to the Administrator during the 5-year pe-12

riod ending on the date of the request by 13

the Administrator; 14

‘‘(ii) require the Administrator, in ac-15

cordance with section 14— 16

‘‘(I) to review each substan-17

tiation— 18

‘‘(aa) submitted pursuant to 19

clause (i) to determine if the 20

claim warrants protection from 21

disclosure; and 22

‘‘(bb) submitted previously 23

by a manufacturer or processor 24

and relied on in lieu of the sub-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

88

•S 697 RS

stantiation required pursuant to 1

clause (i), if the substantiation 2

has not been previously reviewed 3

by the Administrator, to deter-4

mine if the claim warrants pro-5

tection from disclosure; 6

‘‘(II) approve, modify, or deny 7

each claim; and 8

‘‘(III) except as provided in this 9

section and section 14, protect from 10

disclosure information for which the 11

Administrator approves such a claim 12

for a period of 10 years, unless, prior 13

to the expiration of the period— 14

‘‘(aa) the person notifies the 15

Administrator that the person is 16

withdrawing the confidentiality 17

claim, in which case the Adminis-18

trator shall promptly make the 19

information available to the pub-20

lic; or 21

‘‘(bb) the Administrator oth-22

erwise becomes aware that the 23

need for protection from disclo-24

sure can no longer be substan-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

89

•S 697 RS

tiated, in which case the Admin-1

istrator shall take the actions de-2

scribed in section 14(g)(2); and 3

‘‘(iii) encourage manufacturers or 4

processors that have previously made 5

claims to protect the specific identities of 6

chemical substances identified as inactive 7

pursuant to subsection (f)(2) to review and 8

either withdraw or substantiate the claims. 9

‘‘(E) TIMELINE FOR COMPLETION OF RE-10

VIEWS.— 11


shall implement the review plan so as to 13

complete reviews of all claims specified in 14

subparagraph (C) not later than 5 years 15

after the date on which the Administrator 16

compiles the initial list of active substances 17

pursuant to subparagraph (A). 18

‘‘(ii) CONSIDERATIONS.— 19

‘‘(I) IN GENERAL.—The Admin-20

istrator may extend the deadline for 21

completion of the reviews for not more 22

than 2 additional years, after an ade-23

quate public justification, if the Ad-24

ministrator determines that the exten-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

90

•S 697 RS

sion is necessary based on the number 1

of applicable claims needing review 2

and the available resources. 3



goal for the number of reviews to be 6

completed over the course of imple-7

mentation of the plan. 8

‘‘(5) ACTIVE AND INACTIVE SUBSTANCES.— 9


shall maintain and keep current designations of 11

active substances and inactive substances on 12

the list published under paragraph (1). 13

‘‘(B) UPDATE.—The Administrator shall 14

update the list of chemical substances des-15

ignated as active substances as soon as prac-16

ticable after the date of publication of the most 17

recent data reported under— 18

‘‘(i) part 711 of title 40, Code of Fed-19

eral Regulations (or successor regulations); 20

and 21

‘‘(ii) the rules promulgated pursuant 22

to subsection (a)(4). 23

‘‘(C) CHANGE TO ACTIVE STATUS.— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

91

•S 697 RS

‘‘(i) IN GENERAL.—Any person that 1

intends to manufacture or process for a 2

nonexempt commercial purpose a chemical 3

substance that is designated as an inactive 4

substance shall notify the Administrator 5

before the date on which the inactive sub-6

stance is manufactured or processed. 7

‘‘(ii) CONFIDENTIAL CHEMICAL IDEN-8

TITY CLAIMS.—If a person submitting a 9

notice under clause (i) for an inactive sub-10

stance on the confidential portion of the 11

list published under paragraph (1) seeks to 12

maintain an existing claim for protection 13

against disclosure of the specific identity of 14

the inactive substance as confidential, the 15

person shall— 16

‘‘(I) in the notice submitted 17

under clause (i), assert the claim; and 18

‘‘(II) by not later than 30 days 19

after providing the notice under clause 20

(i), substantiate the claim. 21

‘‘(iii) ACTIVE STATUS.—On receiving 22

a notification under clause (i), the Admin-23

istrator shall— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

92

•S 697 RS

‘‘(I) designate the applicable 1

chemical substance as an active sub-2

stance; 3

‘‘(II) pursuant to section 14, 4

promptly review any claim and associ-5

ated substantiation submitted pursu-6

ant to clause (ii) for protection 7

against disclosure of the specific iden-8

tity of the chemical substance and ap-9

prove, modify, or deny the claim; 10



disclosure the specific identity of the 13

chemical substance for which the Ad-14

ministrator approves a claim under 15

subclause (II) for a period of not less 16

than 10 years, unless, prior to the ex-17

piration of the period— 18







lic; or 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

93

•S 697 RS



need for protection from disclo-3

sure can no longer be substan-4

tiated, in which case the Admin-5

istrator shall take the actions de-6

scribed in section 14(g)(2); and 7

‘‘(IV) pursuant to section 4A, re-8

view the priority of the chemical sub-9

stance as the Administrator deter-10

mines to be necessary. 11

‘‘(D) CATEGORY STATUS.—The list of in-12

active substances shall not be considered to be 13

a category for purposes of section 26(c). 14

‘‘(6) INTERIM LIST OF ACTIVE SUBSTANCES.— 15

Prior to the promulgation of the rule required under 16

this subsection, the Administrator shall designate 17

the chemical substances reported under part 711 of 18

title 40, Code of Federal Regulations (or successor 19

regulations), during the reporting period that most 20

closely preceded the date of enactment of the Frank 21

R. Lautenberg Chemical Safety for the 21st Century 22

Act, as the interim list of active substances for the 23

purposes of section 4A. 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

94

•S 697 RS

‘‘(7) PUBLIC PARTICIPATION.—Subject to this 1

subsection, the Administrator shall make available to 2

the public— 3

‘‘(A) the specific identity of each chemical 4

substance on the nonconfidential portion of the 5

list published under paragraph (1) that the Ad-6

ministrator has designated as— 7

‘‘(i) an active substance; or 8

‘‘(ii) an inactive substance; 9

‘‘(B) the accession number, generic name, 10

and, if applicable, premanufacture notice case 11

number for each chemical substance on the con-12

fidential portion of the list published under 13

paragraph (1) for which a claim of confiden-14

tiality was received and approved by the Admin-15

istrator pursuant to section 14; and 16

‘‘(C) subject to section 14(g), the specific 17

identity of any active substance for which— 18

‘‘(i) no claim of protection against dis-19

closure of the specific identity of the active 20

substance pursuant to this subsection was 21

received; 22

‘‘(ii) a claim for protection against 23

disclosure of the specific identity of the ac-24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

95

•S 697 RS

tive substance has been denied by the Ad-1

ministrator; or 2

‘‘(iii) the time period for protection 3


the active substance has expired. 5

‘‘(8) LIMITATION.—No person may assert a 6

new claim under this subsection for protection from 7

disclosure of a specific identity of any active or inac-8

tive chemical substance for which a notice is received 9

under paragraph (4)(A)(i) or (5)(C)(i) that is not on 10

the confidential portion of the list published under 11

paragraph (1). 12

‘‘(9) CERTIFICATION.—Under the rule promul-13

gated under this subsection, manufacturers and 14

processors shall be required— 15

‘‘(A) to certify that each report the manu-16

facturer or processor submits complies with the 17

requirements of the rule, and that any confiden-18

tiality claims are true and correct; and 19

‘‘(B) to retain a record supporting the cer-20

tification for a period of 5 years beginning on 21

the last day of the submission period.’’; 22

(3) in subsection (e)— 23

(A) by striking ‘‘Any person’’ and inserting 24

the following: 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

96

•S 697 RS

‘‘(1) IN GENERAL.—Any person’’; and 1


‘‘(2) APPLICABILITY.—Any person may submit 3

to the Administrator information reasonably sup-4

porting the conclusion that a chemical substance or 5

mixture presents, will present, or does not present a 6

substantial risk of harm to health and the environ-7

ment.’’; and 8

(4) in subsection (f), by striking ‘‘For purposes 9

of this section, the’’ and inserting the following: ‘‘In 10

this section: 11

‘‘(1) ACTIVE SUBSTANCE.—The term ‘active 12

substance’ means a chemical substance— 13

‘‘(A) that has been manufactured or proc-14

essed for a nonexempt commercial purpose at 15

any point during the 10-year period ending on 16

the date of enactment of the Frank R. Lauten-17

berg Chemical Safety for the 21st Century Act; 18

‘‘(B) that is added to the list published 19

under subsection (b)(1) after that date of en-20

actment; or 21

‘‘(C) for which a notice is received under 22

subsection (b)(5)(C). 23

‘‘(2) INACTIVE SUBSTANCE.—The term ‘inactive 24

substance’ means a chemical substance on the list 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

97

•S 697 RS

published under subsection (b)(1) that does not meet 1

any of the criteria described in paragraph (1). 2

‘‘(3) MANUFACTURE; PROCESS.—The’’. 3

SEC. 11. RELATIONSHIP TO OTHER FEDERAL LAWS. 4




(A) in paragraph (1), in the first sen-8

tence— 9

(i) by striking ‘‘presents or will 10

present an unreasonable risk to health or 11

the environment’’ and inserting ‘‘does not 12

meet the safety standard’’; and 13

(ii) by striking ‘‘such risk’’ the first 14

place it appears and inserting ‘‘the risk 15

posed by the substance or mixture’’; 16


lowing subparagraph (B), by striking ‘‘section 6 18

or 7’’ and inserting ‘‘section 6(d) or section 7’’; 19

and 20

(C) in paragraph (3), by striking ‘‘section 21

6 or 7’’ and inserting ‘‘section 6(d) or 7’’; 22

(2) in subsection (d), in the first sentence, by 23

striking ‘‘Health, Education, and Welfare’’ and in-24

serting ‘‘Health and Human Services’’; and 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

98

•S 697 RS

(3) by adding at the end the following: 1

‘‘(e) EXPOSURE INFORMATION.—If the Adminis-2

trator obtains information related to exposures or releases 3

of a chemical substance that may be prevented or reduced 4

under another Federal law, including laws not adminis-5

tered by the Administrator, the Administrator shall make 6

such information available to the relevant Federal agency 7

or office of the Environmental Protection Agency.’’. 8

SEC. 12. RESEARCH, DEVELOPMENT, COLLECTION, DIS-9

SEMINATION, AND UTILIZATION OF DATA. 10


U.S.C. 2609) is amended by striking ‘‘Health, Education, 12

and Welfare’’ each place it appears and inserting ‘‘Health 13

and Human Services’’. 14

SEC. 13. EXPORTS. 15



(1) in subsection (a), by striking paragraph (2) 18

and inserting the following: 19

‘‘(2) EXCEPTION.—Paragraph (1) shall not 20

apply to any chemical substance that the Adminis-21

trator determines— 22

‘‘(A) under section 5 is not likely to meet 23

the safety standard; or 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

99

•S 697 RS

‘‘(B) under section 6 does not meet the 1

safety standard. 2

‘‘(3) WAIVERS.—For a mixture or article con-3

taining a chemical substance described in paragraph 4

(2), the Administrator may— 5

‘‘(A) determine that paragraph (1) shall 6

not apply to the mixture or article; or 7

‘‘(B) establish a threshold concentration in 8

a mixture or article at which paragraph (1) 9

shall not apply. 10

‘‘(4) TESTING.—The Administrator may re-11

quire testing under section 4 of any chemical sub-12

stance or mixture exempted from this Act under 13

paragraph (1) for the purpose of determining wheth-14

er the chemical substance or mixture meets the safe-15

ty standard within the United States.’’; 16

(2) by striking subsection (b) and inserting the 17

following: 18

‘‘(b) NOTICE.— 19

‘‘(1) IN GENERAL.—A person shall notify the 20

Administrator that the person is exporting or in-21

tends to export to a foreign country— 22

‘‘(A) a chemical substance or a mixture 23

containing a chemical substance that the Ad-24

ministrator has determined under section 5 is 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

100

•S 697 RS

not likely to meet the safety standard and for 1

which a prohibition or other restriction has 2

been proposed or established under that section; 3

‘‘(B) a chemical substance or a mixture 4

containing a chemical substance that the Ad-5

ministrator has determined under section 6 6

does not meet the safety standard and for 7

which a prohibition or other restriction has 8

been proposed or established under that section; 9

‘‘(C) a chemical substance for which the 10

United States is obligated by treaty to provide 11

export notification; 12

‘‘(D) a chemical substance or mixture sub-13

ject to a prohibition or other restriction pursu-14

ant to a rule, order, or consent agreement in ef-15

fect under this Act; or 16

‘‘(E) a chemical substance or mixture for 17

which the submission of information is required 18

under section 4. 19

‘‘(2) RULES.— 20


shall promulgate rules to carry out paragraph 22

(1). 23


pursuant to subparagraph (A) shall— 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

101

•S 697 RS

‘‘(i) include such exemptions as the 1

Administrator determines to be appro-2

priate, which may include exemptions iden-3

tified under section 5(h); and 4

‘‘(ii) indicate whether, or to what ex-5

tent, the rules apply to articles containing 6

a chemical substance or mixture described 7

in paragraph (1). 8

‘‘(3) NOTIFICATION.—The Administrator shall 9

submit to the government of each country to which 10

a chemical substance or mixture is exported— 11

‘‘(A) for a chemical substance or mixture 12

described in subparagraph (A), (B), or (D) of 13

paragraph (1), a notice of the determination, 14

rule, order, consent agreement, requirement, or 15

designation; 16

‘‘(B) for a chemical substance described in 17

paragraph (1)(C), a notice that satisfies the ob-18

ligation of the United States under the applica-19

ble treaty; and 20

‘‘(C) for a chemical substance or mixture 21

described in paragraph (1)(E), a notice of avail-22

ability of the information on the chemical sub-23

stance or mixture submitted to the Adminis-24

trator.’’; and 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

102

•S 697 RS

(3) in subsection (c)— 1


(B) by redesignating paragraphs (4) 3


spectively. 5

SEC. 14. IMPORTS. 6


U.S.C. 2612) is amended to read as follows: 8

‘‘SEC. 13. IMPORTS. 9

‘‘(a) REFUSAL OF ENTRY.— 10

‘‘(1) IN GENERAL.—The Secretary of Homeland 11

Security shall refuse entry into the customs territory 12

of the United States (as defined in general note 2 13

to the Harmonized Tariff Schedule of the United 14

States) any chemical substance, mixture, or article 15

containing a chemical substance or mixture offered 16

for such entry, if— 17

‘‘(A) the Administrator— 18

‘‘(i) has determined under section 6(c) 19

that the chemical substance or mixture 20

does not meet the safety standard; and 21

‘‘(ii) has promulgated a rule pursuant 22

to section 6(d) banning the chemical sub-23

stance or mixture, as of the effective date 24

of the rule; 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

103

•S 697 RS

‘‘(B) the chemical substance— 1

‘‘(i) is not included on the list under 2

section 8(b)(1); and 3

‘‘(ii) is not exempt from any require-4

ment to be included on that list by this 5

title or a rule promulgated by the Adminis-6

trator pursuant to this title; or 7

‘‘(C) the chemical substance, mixture, or 8

any article containing the chemical substance or 9

mixture is offered for entry in violation of— 10

‘‘(i) a rule, consent agreement, or 11

order in effect under this Act; or 12

‘‘(ii) an order issued in a civil action 13

brought under section 7 or title IV. 14

‘‘(2) PROCEDURE.— 15


graph (B), if a chemical substance, mixture, or 17

article containing a chemical substance or mix-18

ture is refused entry under paragraph (1), the 19

Secretary of Homeland Security— 20

‘‘(i) shall notify the consignee of the 21

entry of the refusal; 22

‘‘(ii) shall not release the chemical 23

substance or mixture to the consignee; and 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

104

•S 697 RS

‘‘(iii) shall cause the disposal or stor-1

age of the chemical substance or mixture 2

under such rules as the Secretary may pre-3

scribe, if the chemical substance or mix-4

ture has not been exported by the con-5

signee during the 90-day period beginning 6

on the date of receipt of the notice of the 7

refused entry. 8

‘‘(B) EXCEPTION.— 9

‘‘(i) IN GENERAL.—The Secretary of 10

Homeland Security, pending a review by 11

the Administrator, may release to the con-12

signee the chemical substance or mixture if 13

the consignee— 14

‘‘(I) executes a bond for the 15

amount of the full invoice of the 16

chemical substance or mixture (as set 17

forth in the customs entry); and 18

‘‘(II) pays a duty on the chemical 19

substance or mixture. 20

‘‘(ii) ADMINISTRATION.—If a con-21

signee fails to return a chemical substance 22

or mixture released to that consignee 23

under clause (i) for any cause to the cus-24

tody of the Secretary of Homeland Secu-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

105

•S 697 RS

rity on demand, the consignee shall be lia-1

ble to the United States for liquidated 2

damages equal to the full amount of the 3

bond executed under clause (i)(I). 4

‘‘(C) STORAGE.—All charges for storage, 5

cartage, and labor on or for the disposal of a 6

chemical substance or mixture that is refused 7

entry or released under this subsection shall be 8

paid by the owner or consignee, and a default 9

on that payment shall constitute a lien against 10

any future entry made by the owner or con-11

signee. 12

‘‘(b) CERTIFICATION.— 13

‘‘(1) IN GENERAL.—A person offering a chem-14

ical substance or mixture subject to this Act for 15

entry into the customs territory of the United States 16

shall certify to the Secretary of Homeland Security 17

that— 18

‘‘(A) after reasonable inquiry and to the 19

best knowledge and belief of the person, the 20

chemical substance or mixture is in compliance 21

with any applicable rule, consent agreement, or 22

order under section 5 or 6; and 23

‘‘(B) the chemical substance— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

106

•S 697 RS

‘‘(i) is included on the list under sec-1

tion 8(b)(1); or 2

‘‘(ii) is exempt from any requirement 3

to be included on that list by this title or 4

a rule promulgated by the Administrator 5

pursuant to this title. 6

‘‘(2) ARTICLES.— 7

‘‘(A) IN GENERAL.—The Administrator, by 8

rule, may require certification under paragraph 9

(1) for an article containing a chemical sub-10

stance or mixture that is subject to rule under 11

section 5 or 6. 12

‘‘(B) REQUIREMENT.—The rule under sub-13

paragraph (A) shall identify, with reasonable 14

specificity, the types of articles, including parts 15

or components of articles, that will be subject to 16

the certification requirement. 17

‘‘(C) FACTORS FOR CONSIDERATION.—In 18

determining the need for and content of a cer-19

tification rule under this paragraph, the Admin-20

istrator shall take into consideration— 21

‘‘(i) the utility of the certification to 22

enforcement of the applicable rule, consent 23

agreement, or order under section 5 or 6; 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

107

•S 697 RS

‘‘(ii) the contribution of imported arti-1

cles to the potential risk presented by ex-2

posure to the chemical substance or mix-3

ture subject to rule under section 5 or 6; 4

‘‘(iii) the impact on commerce and po-5

tential for the certification to impede or 6

disrupt import of articles; 7

‘‘(iv) the frequency or duration of the 8

certification requirement; and 9

‘‘(v) specification of the concentration 10

of a chemical substance in an article that 11

would subject the article to the certifi-12

cation requirement. 13

‘‘(3) REASONABLE INQUIRY.— 14

‘‘(A) IN GENERAL.—For purposes of a cer-15

tification under paragraph (1), reasonable in-16

quiry shall include good faith reliance by an im-17

porter on— 18

‘‘(i) a safety data sheet or similar dec-19

laration provided by a supplier that docu-20

ments the specific identity of the chemical 21

substance or the specific identities of all 22

chemical substances in a mixture; or 23

‘‘(ii) for chemical substances or mix-24

tures claimed by the supplier as confiden-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

108

•S 697 RS

tial, or not otherwise disclosed by the sup-1

plier, a certification by the supplier that 2

the imported chemical substance or mix-3

ture satisfies the applicable certification re-4

quirements under paragraph (1). 5

‘‘(B) ARTICLES.—For purposes of a cer-6

tification under paragraph (2), reasonable in-7

quiry shall include good faith reliance by an im-8

porter on a certification by the supplier that the 9

imported article satisfies the applicable certifi-10

cation requirements in a rule promulgated pur-11

suant to paragraph (2). 12

‘‘(4) INFORMATION REGARDING IDENTITY.— 13

For purposes of this subsection, the Administrator 14

shall provide publicly accessible information regard-15

ing the identity of a chemical substance or mixture 16

subject to rule under this Act that would be readily 17

understood in import transactions. 18

‘‘(c) NOTICE.—A person offering a chemical sub-19

stance for entry into the customs territory of the United 20

States shall notify the Secretary of Homeland Security 21

if— 22

‘‘(1) the chemical substance or chemical sub-23

stance in a mixture is a high-priority substance; 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

109

•S 697 RS


stance in a mixture is 1 for which the United States 2

is obligated to provide export notification by treaty; 3

or 4


stance in a mixture— 6

‘‘(A) is the subject of a safety assessment 7

and safety determination conducted pursuant to 8

section 6; and 9

‘‘(B) has been found not to meet the safety 10

standard. 11

‘‘(d) RULES.— 12

‘‘(1) IN GENERAL.—The Secretary of Homeland 13

Security, after consultation with the Administrator, 14

shall promulgate rules to carry out this section. 15

‘‘(2) APPLICATION.—The rules under para-16

graph (1) may modify the application of any require-17

ment of this section, as appropriate for the efficient 18

and effective implementation of this Act.’’. 19

SEC. 15. CONFIDENTIAL INFORMATION. 20



‘‘SEC. 14. CONFIDENTIAL INFORMATION. 23

‘‘(a) IN GENERAL.—Except as otherwise provided in 24

this section, the Administrator shall not disclose informa-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

110

•S 697 RS

tion that is exempt from disclosure pursuant to subsection 1

(a) of section 552 of title 5, United States Code, under 2

subsection (b)(4) of that section— 3

‘‘(1) that is reported to, or otherwise obtained 4

by, the Administrator under this Act; and 5

‘‘(2) for which the requirements of subsection 6

(d) are met. 7

‘‘(b) INFORMATION GENERALLY PROTECTED FROM 8

DISCLOSURE.—The following information specific to, and 9

submitted by, a manufacturer, processor, or distributor 10

that meets the requirements of subsections (a) and (d) 11

shall be presumed to be protected from disclosure, subject 12

to the condition that nothing in this Act prohibits the dis-13

closure of any such information through discovery, sub-14

poena, other court order, or any other judicial process oth-15

erwise allowed under applicable Federal or State law: 16

‘‘(1) Specific information describing the proc-17

esses used in manufacture or processing of a chem-18

ical substance, mixture, or article. 19

‘‘(2) Marketing and sales information. 20

‘‘(3) Information identifying a supplier or cus-21

tomer. 22

‘‘(4) Details of the full composition of a mixture 23

and the respective percentages of constituents. 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

111

•S 697 RS

‘‘(5) Specific information regarding the use, 1

function, or application of a chemical substance or 2

mixture in a process, mixture, or product. 3

‘‘(6) Specific production or import volumes of 4

the manufacturer and specific aggregated volumes 5

across manufacturers, if the Administrator deter-6

mines that disclosure of the specific aggregated vol-7

umes would reveal confidential information. 8

‘‘(7) Except as otherwise provided in this sec-9

tion, the specific identity of a chemical substance 10

prior to the date on which the chemical substance is 11

first offered for commercial distribution, including 12

the chemical name, molecular formula, Chemical Ab-13

stracts Service number, and other information that 14

would identify a specific chemical substance, if— 15

‘‘(A) the specific identity was claimed as 16

confidential information at the time it was sub-17

mitted in a notice under section 5; and 18

‘‘(B) the claim— 19

‘‘(i) is not subject to an exception 20

under subsection (e); or 21

‘‘(ii) has not subsequently been with-22

drawn or found by the Administrator not 23

to warrant protection as confidential infor-24

mation under subsection (f)(2) or (g). 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

112

•S 697 RS

‘‘(c) INFORMATION NOT PROTECTED FROM DISCLO-1

SURE.—Notwithstanding subsections (a) and (b), the fol-2

lowing information shall not be protected from disclosure: 3

‘‘(1) INFORMATION FROM HEALTH AND SAFETY 4

STUDIES.— 5


graph (B), subsection (a) does not prohibit the 7

disclosure of— 8

‘‘(i) any health and safety study that 9

is submitted under this Act with respect 10

to— 11

‘‘(I) any chemical substance or 12

mixture that, on the date on which 13

the study is to be disclosed, has been 14

offered for commercial distribution; or 15

‘‘(II) any chemical substance or 16

mixture for which— 17

‘‘(aa) testing is required 18

under section 4; or 19

‘‘(bb) a notification is re-20

quired under section 5; or 21

‘‘(ii) any information reported to, or 22

otherwise obtained by, the Administrator 23

from a health and safety study relating to 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

113

•S 697 RS


in subclause (I) or (II) of clause (i). 2

‘‘(B) EFFECT OF PARAGRAPH.—Nothing 3

in this paragraph authorizes the release of any 4

information that discloses— 5

‘‘(i) a process used in the manufac-6

turing or processing of a chemical sub-7

stance or mixture; or 8

‘‘(ii) in the case of a mixture, the por-9

tion of the mixture comprised by any 10

chemical substance in the mixture. 11

‘‘(2) CERTAIN REQUESTS.—If a request is made 12

to the Administrator under section 552(a) of title 5, 13

United States Code, for information that is de-14

scribed in paragraph (1) that is not described in 15

paragraph (1)(B), the Administrator may not deny 16

the request on the basis of section 552(b)(4) of title 17

5, United States Code. 18

‘‘(3) OTHER INFORMATION NOT PROTECTED 19

FROM DISCLOSURE.—The following information is 20

not protected from disclosure under this section: 21

‘‘(A) For information submitted after the 22

date of enactment of the Frank R. Lautenberg 23

Chemical Safety for the 21st Century Act, the 24

specific identity of a chemical substance as of 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

114

•S 697 RS

the date on which the chemical substance is 1

first offered for commercial distribution, if the 2

person submitting the information does not 3

meet the requirements of subsection (d). 4

‘‘(B) A safety assessment developed, or a 5

safety determination made, under section 6. 6

‘‘(C) Any general information describing 7

the manufacturing volumes, expressed as spe-8

cific aggregated volumes or, if the Adminis-9

trator determines that disclosure of specific ag-10

gregated volumes would reveal confidential in-11

formation, expressed in ranges. 12

‘‘(D) A general description of a process 13

used in the manufacture or processing and in-14

dustrial, commercial, or consumer functions and 15

uses of a chemical substance, mixture, or article 16

containing a chemical substance or mixture, in-17

cluding information specific to an industry or 18

industry sector that customarily would be 19

shared with the general public or within an in-20

dustry or industry sector. 21

‘‘(4) MIXED CONFIDENTIAL AND NONCON-22

FIDENTIAL INFORMATION.—Any information that is 23

otherwise eligible for protection under this section 24

and contained in a submission of information de-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

115

•S 697 RS

scribed in this subsection shall be protected from 1

disclosure, if the submitter complies with subsection 2

(d), subject to the condition that information in the 3

submission that is not eligible for protection against 4

disclosure shall be disclosed. 5

‘‘(5) BAN OR PHASE-OUT.—If the Adminis-6

trator promulgates a rule pursuant to section 6(d) 7

that establishes a ban or phase-out of the manufac-8

ture, processing, or distribution in commerce of a 9

chemical substance— 10

‘‘(A) any protection from disclosure pro-11

vided under this section with respect to infor-12

mation relating to the chemical substance shall 13

no longer apply; and 14

‘‘(B) the Administrator promptly shall 15

make the information public. 16

‘‘(d) REQUIREMENTS FOR CONFIDENTIALITY 17

CLAIMS.— 18

‘‘(1) ASSERTION OF CLAIMS.— 19

‘‘(A) IN GENERAL.—A person seeking to 20

protect any information submitted under this 21

Act from disclosure (including information de-22

scribed in subsection (b)) shall assert to the Ad-23

ministrator a claim for protection concurrent 24

with submission of the information, in accord-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

116

•S 697 RS

ance with such rules regarding a claim for pro-1

tection from disclosure as the Administrator 2

has promulgated or may promulgate pursuant 3

to this title. 4

‘‘(B) INCLUSION.—An assertion of a claim 5

under subparagraph (A) shall include a state-6

ment that the person has— 7

‘‘(i) taken reasonable measures to pro-8

tect the confidentiality of the information; 9

‘‘(ii) determined that the information 10

is not required to be disclosed or otherwise 11

made available to the public under any 12

other Federal law; 13

‘‘(iii) a reasonable basis to conclude 14

that disclosure of the information is likely 15

to cause substantial harm to the competi-16

tive position of the person; and 17

‘‘(iv) a reasonable basis to believe that 18

the information is not readily discoverable 19

through reverse engineering. 20

‘‘(C) SPECIFIC CHEMICAL IDENTITY.—In 21

the case of a claim under subparagraph (A) for 22

protection against disclosure of a specific chem-23

ical identity, the claim shall include a struc-24

turally descriptive generic name for the chem-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

117

•S 697 RS

ical substance that the Administrator may dis-1

close to the public, subject to the condition that 2

the generic name shall— 3

‘‘(i) conform with guidance prescribed 4

by the Administrator under paragraph 5

(3)(A); and 6

‘‘(ii) describe the chemical structure 7

of the substance as specifically as prac-8

ticable while protecting those features of 9

the chemical structure— 10

‘‘(I) that are considered to be 11

confidential; and 12

‘‘(II) the disclosure of which 13

would be likely to harm the competi-14

tive position of the person. 15

‘‘(D) PUBLIC INFORMATION.—No person 16

may assert a claim under this section for pro-17

tection from disclosure of information that is al-18

ready publicly available. 19

‘‘(2) ADDITIONAL REQUIREMENTS FOR CON-20

FIDENTIALITY CLAIMS.—Except for information de-21

scribed in paragraphs (1) through (7) of subsection 22

(b), a person asserting a claim to protect informa-23

tion from disclosure under this Act shall substan-24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

118

•S 697 RS

tiate the claim, in accordance with the rules promul-1

gated and guidance issued by the Administrator. 2


velop guidance regarding— 4

‘‘(A) the determination of structurally de-5

scriptive generic names, in the case of claims 6

for the protection against disclosure of specific 7

chemical identity; and 8

‘‘(B) the content and form of the state-9

ments of need and agreements required under 10

paragraphs (4), (5), and (6) of subsection (e). 11

‘‘(4) CERTIFICATION.—An authorized official of 12

a person described in paragraph (1)(A) shall certify 13

that the information that has been submitted is true 14

and correct. 15

‘‘(e) EXCEPTIONS TO PROTECTION FROM DISCLO-16

SURE.—Information described in subsection (a) shall be 17

disclosed if— 18

‘‘(1) the information is to be disclosed to an of-19

ficer or employee of the United States in connection 20

with the official duties of the officer or employee— 21

‘‘(A) under any law for the protection of 22

health or the environment; or 23

‘‘(B) for a specific law enforcement pur-24

pose; 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

119

•S 697 RS

‘‘(2) the information is to be disclosed to a con-1

tractor of the United States and employees of that 2

contractor— 3

‘‘(A) if, in the opinion of the Adminis-4

trator, the disclosure is necessary for the satis-5

factory performance by the contractor of a con-6

tract with the United States for the perform-7

ance of work in connection with this Act; and 8

‘‘(B) subject to such conditions as the Ad-9

ministrator may specify; 10

‘‘(3) the Administrator determines that disclo-11

sure is necessary to protect health or the environ-12

ment; 13

‘‘(4) the information is to be disclosed to a 14

State or political subdivision of a State, on written 15

request, for the purpose of development, administra-16

tion, or enforcement of a law, if— 17

‘‘(A) 1 or more applicable agreements with 18

the Administrator that conform with the guid-19

ance issued under subsection (d)(3)(B) ensure 20

that the recipient will take appropriate meas-21

ures, and has adequate authority, to maintain 22

the confidentiality of the information in accord-23

ance with procedures comparable to the proce-24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

120

•S 697 RS

dures used by the Administrator to safeguard 1

the information; and 2

‘‘(B) the Administrator notifies the person 3

that submitted the information that the infor-4

mation has been disclosed to the State or polit-5

ical subdivision of a State; 6

‘‘(5) a health or environmental professional em-7

ployed by a Federal or State agency or a treating 8

physician or nurse in a nonemergency situation pro-9

vides a written statement of need and agrees to sign 10

a written confidentiality agreement with the Admin-11

istrator, subject to the conditions that— 12

‘‘(A) the statement of need and confiden-13

tiality agreement shall conform with the guid-14

ance issued under subsection (d)(3)(B); 15

‘‘(B) the written statement of need shall be 16

a statement that the person has a reasonable 17

basis to suspect that— 18

‘‘(i) the information is necessary for, 19

or will assist in— 20

‘‘(I) the diagnosis or treatment of 21

1 or more individuals; or 22

‘‘(II) responding to an environ-23

mental release or exposure; and 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

121

•S 697 RS

‘‘(ii) 1 or more individuals being diag-1

nosed or treated have been exposed to the 2

chemical substance concerned, or an envi-3

ronmental release or exposure has oc-4

curred; and 5

‘‘(C) the confidentiality agreement shall 6

provide that the person will not use the infor-7

mation for any purpose other than the health or 8

environmental needs asserted in the statement 9

of need, except as otherwise may be authorized 10

by the terms of the agreement or by the person 11

submitting the information to the Adminis-12

trator, except that nothing in this Act prohibits 13

the disclosure of any such information through 14

discovery, subpoena, other court order, or any 15

other judicial process otherwise allowed under 16

applicable Federal or State law; 17

‘‘(6) in the event of an emergency, a treating 18

physician, nurse, agent of a poison control center, 19

public health or environmental official of a State or 20

political subdivision of a State, or first responder 21

(including any individual duly authorized by a Fed-22

eral agency, State, or political subdivision of a State 23

who is trained in urgent medical care or other emer-24

gency procedures, including a police officer, fire-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

122

•S 697 RS

fighter, or emergency medical technician) requests 1

the information, subject to the conditions that— 2

‘‘(A) the treating physician, nurse, agent, 3

public health or environmental official of a 4

State or a political subdivision of a State, or 5

first responder shall have a reasonable basis to 6

suspect that— 7

‘‘(i) a medical or public health or en-8

vironmental emergency exists; 9

‘‘(ii) the information is necessary for, 10

or will assist in, emergency or first-aid di-11

agnosis or treatment; or 12

‘‘(iii) 1 or more individuals being di-13

agnosed or treated have likely been ex-14

posed to the chemical substance concerned, 15

or a serious environmental release of or ex-16

posure to the chemical substance con-17

cerned has occurred; 18

‘‘(B) if requested by the person submitting 19

the information to the Administrator, the treat-20

ing physician, nurse, agent, public health or en-21

vironmental official of a State or a political sub-22

division of a State, or first responder shall, as 23

described in paragraph (5)— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

123

•S 697 RS

‘‘(i) provide a written statement of 1

need; and 2

‘‘(ii) agree to sign a confidentiality 3

agreement; and 4

‘‘(C) the written confidentiality agreement 5

or statement of need shall be submitted as soon 6

as practicable, but not necessarily before the in-7

formation is disclosed; 8

‘‘(7) the Administrator determines that disclo-9

sure is relevant in a proceeding under this Act, sub-10

ject to the condition that the disclosure shall be 11

made in such a manner as to preserve confidentiality 12

to the maximum extent practicable without impair-13

ing the proceeding; 14

‘‘(8) the information is to be disclosed, on writ-15

ten request of any duly authorized congressional 16

committee, to that committee; or 17

‘‘(9) the information is required to be disclosed 18

or otherwise made public under any other provision 19

of Federal law. 20

‘‘(f) DURATION OF PROTECTION FROM DISCLO-21

SURE.— 22

‘‘(1) IN GENERAL.— 23

‘‘(A) INFORMATION PROTECTED FROM DIS-24

CLOSURE.—Subject to paragraph (2), the Ad-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

124

•S 697 RS

ministrator shall protect from disclosure infor-1

mation that meets the requirements of sub-2

section (d) for a period of 10 years, unless, 3

prior to the expiration of the period— 4

‘‘(i) an affected person notifies the 5

Administrator that the person is with-6

drawing the confidentiality claim, in which 7

case the Administrator shall promptly 8

make the information available to the pub-9

lic; or 10

‘‘(ii) the Administrator otherwise be-11

comes aware that the need for protection 12

from disclosure can no longer be substan-13

tiated, in which case the Administrator 14

shall take the actions described in sub-15

section (g)(2). 16

‘‘(B) EXTENSIONS.— 17

‘‘(i) IN GENERAL.—Not later than the 18

date that is 60 days before the expiration 19

of the period described in subparagraph 20

(A), the Administrator shall provide to the 21

person that asserted the claim a notice of 22

the impending expiration of the period. 23

‘‘(ii) STATEMENT.— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

125

•S 697 RS

‘‘(I) IN GENERAL.—Not later 1

than the date that is 30 days before 2

the expiration of the period described 3

in subparagraph (A), a person re-4

asserting the relevant claim shall sub-5

mit to the Administrator a statement 6

substantiating, in accordance with 7

subsection (d)(2), the need to extend 8

the period. 9

‘‘(II) ACTION BY ADMINIS-10

TRATOR.—Not later than the date 11

that is 30 days after the date of re-12

ceipt of a statement under subclause 13

(I), the Administrator shall— 14

‘‘(aa) review the request; 15

‘‘(bb) make a determination 16

regarding whether the informa-17

tion for which the request is 18

made continues to meet the rel-19

evant criteria established under 20

this section; and 21

‘‘(cc)(AA) grant an exten-22

sion of not more than 10 years; 23

or 24

‘‘(BB) deny the claim. 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

126

•S 697 RS

‘‘(C) NO LIMIT ON NUMBER OF EXTEN-1

SIONS.—There shall be no limit on the number 2

of extensions granted under subparagraph (B), 3

if the Administrator determines that the rel-4

evant statement under subparagraph 5

(B)(ii)(I)— 6

‘‘(i) establishes the need to extend the 7

period; and 8

‘‘(ii) meets the requirements estab-9

lished by the Administrator. 10

‘‘(2) REVIEW AND RESUBSTANTIATION.— 11

‘‘(A) DISCRETION OF ADMINISTRATOR.— 12

The Administrator may review, at any time, a 13

claim for protection against disclosure under 14

subsection (a) for information submitted to the 15

Administrator regarding a chemical substance 16

and require any person that has claimed protec-17

tion for that information, whether before, on, or 18

after the date of enactment of the Frank R. 19


tury Act, to withdraw or reassert and substan-21

tiate or resubstantiate the claim in accordance 22

with this section— 23


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

127

•S 697 RS

‘‘(i) after the chemical substance is 1

identified as a high-priority substance 2

under section 4A; 3

‘‘(ii) for any chemical substance for 4

which the Administrator has made a deter-5

mination under section 6(c)(1)(C); 6

‘‘(iii) for any inactive chemical sub-7

stance identified under section 8(b)(5); or 8

‘‘(iv) in limited circumstances, if the 9

Administrator determines that disclosure 10

of certain information currently protected 11

from disclosure would assist the Adminis-12

trator in conducting safety assessments 13

and safety determinations under sub-14

sections (b) and (c) of section 6 or promul-15

gating rules pursuant to section 6(d), sub-16

ject to the condition that the information 17

shall not be disclosed unless the claimant 18

withdraws the claim or the Administrator 19

determines that the information does not 20

meet the requirements of subsection (d). 21

‘‘(B) REVIEW REQUIRED.—The Adminis-22

trator shall review a claim for protection from 23

disclosure under subsection (a) for information 24

submitted to the Administrator regarding a 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

128

•S 697 RS

chemical substance and require any person that 1

has claimed protection for that information, 2

whether before, on, or after the date of enact-3

ment of the Frank R. Lautenberg Chemical 4

Safety for the 21st Century Act, to withdraw or 5

reassert and substantiate or resubstantiate the 6

claim in accordance with this section— 7

‘‘(i) as necessary to comply with a re-8

quest for information received by the Ad-9

ministrator under section 552 of title 5, 10

United States Code; 11

‘‘(ii) if information available to the 12

Administrator provides a basis that the re-13

quirements of section 552(b)(4) of title 5, 14

United States Code, are no longer met; or 15

‘‘(iii) for any substance for which the 16

Administrator has made a determination 17

under section 6(c)(1)(B). 18

‘‘(C) ACTION BY RECIPIENT.—If the Ad-19

ministrator makes a request under subpara-20

graph (A) or (B), the recipient of the request 21

shall— 22

‘‘(i) reassert and substantiate or re-23

substantiate the claim; or 24

‘‘(ii) withdraw the claim. 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

129

•S 697 RS

‘‘(D) PERIOD OF PROTECTION.—Protec-1

tion from disclosure of information subject to a 2

claim that is reviewed and approved by the Ad-3

ministrator under this paragraph shall be ex-4

tended for a period of 10 years from the date 5

of approval, subject to any subsequent request 6

by the Administrator under this paragraph. 7

‘‘(3) UNIQUE IDENTIFIER.—The Administrator 8

shall— 9

‘‘(A)(i) develop a system to assign a 10

unique identifier to each specific chemical iden-11

tity for which the Administrator approves a re-12

quest for protection from disclosure, other than 13

a specific chemical identity or structurally de-14

scriptive generic term; and 15

‘‘(ii) apply that identifier consistently to all 16

information relevant to the applicable chemical 17

substance; 18

‘‘(B) annually publish and update a list of 19

chemical substances, referred to by unique iden-20

tifier, for which claims to protect the specific 21

chemical identity from disclosure have been ap-22

proved, including the expiration date for each 23

such claim; 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

130

•S 697 RS

‘‘(C) ensure that any nonconfidential infor-1

mation received by the Administrator with re-2

spect to such a chemical substance during the 3

period of protection from disclosure— 4

‘‘(i) is made public; and 5

‘‘(ii) identifies the chemical substance 6

using the unique identifier; and 7

‘‘(D) for each claim for protection of spe-8

cific chemical identity that has been denied by 9

the Administrator on expiration of the period 10

for appeal under subsection (g)(3), that has ex-11

pired, or that has been withdrawn by the sub-12

mitter, provide public access to the specific 13

chemical identity clearly linked to all noncon-14

fidential information received by the Adminis-15

trator with respect to the chemical substance. 16

‘‘(g) DUTIES OF ADMINISTRATOR.— 17

‘‘(1) DETERMINATION.— 18


subsection (b), the Administrator shall, subject 20

to subparagraph (C), not later than 90 days 21

after the receipt of a claim under subsection 22

(d), and not later than 30 days after the receipt 23

of a request for extension of a claim under sub-24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

131

•S 697 RS

section (f), review and approve, modify, or deny 1

the claim or request. 2

‘‘(B) DENIAL OR MODIFICATION.— 3

‘‘(i) IN GENERAL.—Except as pro-4

vided in subsections (c) and (f), the Ad-5

ministrator shall deny a claim to protect a 6

chemical identity from disclosure only if 7

the person that has submitted the claim 8

fails to meet the requirements of sub-9

sections (a) and (d). 10

‘‘(ii) REASONS FOR DENIAL OR MODI-11

FICATION.—The Administrator shall pro-12

vide to a person that has submitted a 13

claim described in clause (i) a written 14

statement of the reasons for the denial or 15

modification of the claim. 16

‘‘(C) SUBSETS.—The Administrator 17

shall— 18

‘‘(i) except for claims described in 19

subsection (b)(7), review all claims under 20

this section for the protection against dis-21

closure of the specific identity of a chem-22

ical substance; and 23


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

132

•S 697 RS

‘‘(ii) review a representative subset, 1

comprising at least 25 percent, of all other 2

claims for protection against disclosure. 3

‘‘(D) EFFECT OF FAILURE TO ACT.—The 4

failure of the Administrator to make a decision 5

regarding a claim for protection against disclo-6

sure or extension under this section shall not be 7

the basis for denial or elimination of a claim for 8

protection against disclosure. 9

‘‘(2) NOTIFICATION.— 10


subparagraph (B) and subsections (c), (e), and 12

(f), if the Administrator denies or modifies a 13

claim under paragraph (1), the Administrator 14

shall notify, in writing and by certified mail, the 15

person that submitted the claim of the intent of 16

the Administrator to release the information. 17

‘‘(B) RELEASE OF INFORMATION.— 18

‘‘(i) IN GENERAL.—Except as pro-19

vided in clause (ii), the Administrator shall 20

not release information under this sub-21

section until the date that is 30 days after 22

the date on which the person that sub-23

mitted the request receives notification 24

under subparagraph (A). 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

133

•S 697 RS

‘‘(ii) EXCEPTIONS.— 1

‘‘(I) IN GENERAL.—For informa-2

tion under paragraph (3) or (8) of 3

subsection (e), the Administrator shall 4

not release that information until the 5

date that is 15 days after the date on 6

which the person that submitted the 7

claim receives a notification, unless 8

the Administrator determines that re-9

lease of the information is necessary 10

to protect against an imminent and 11

substantial harm to health or the en-12

vironment, in which case no prior no-13

tification shall be necessary. 14

‘‘(II) NO NOTIFICATION.—For 15

information under paragraph (1), (2), 16

(6), (7), or (9) of subsection (e), no 17

prior notification shall be necessary. 18

‘‘(3) APPEALS.— 19

‘‘(A) IN GENERAL.—If a person receives a 20

notification under paragraph (2) and believes 21

disclosure of the information is prohibited 22

under subsection (a), before the date on which 23

the information is to be released, the person 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

134

•S 697 RS

may bring an action to restrain disclosure of 1

the information in— 2

‘‘(i) the United States district court of 3

the district in which the complainant re-4

sides or has the principal place of business; 5

or 6

‘‘(ii) the United States District Court 7

for the District of Columbia. 8

‘‘(B) NO DISCLOSURE.—The Adminis-9

trator shall not disclose any information that is 10

the subject of an appeal under this section be-11

fore the date on which the applicable court 12

rules on an action under subparagraph (A). 13

‘‘(4) ADMINISTRATION.—In carrying out this 14

subsection, the Administrator shall use the proce-15

dures described in part 2 of title 40, Code of Fed-16

eral Regulations (or successor regulations). 17

‘‘(h) CRIMINAL PENALTY FOR WRONGFUL DISCLO-18

SURE.— 19

‘‘(1) OFFICERS AND EMPLOYEES OF UNITED 20

STATES.— 21

‘‘(A) IN GENERAL.—Subject to paragraph 22

(2), a current or former officer or employee of 23

the United States described in subparagraph 24

(B) shall be guilty of a misdemeanor and fined 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

135

•S 697 RS

under title 18, United States Code, or impris-1

oned for not more than 1 year, or both. 2

‘‘(B) DESCRIPTION.—A current or former 3

officer or employee of the United States re-4

ferred to in subparagraph (A) is a current or 5

former officer or employee of the United States 6

who— 7

‘‘(i) by virtue of that employment or 8

official position has obtained possession of, 9

or has access to, material the disclosure of 10

which is prohibited by subsection (a); and 11

‘‘(ii) knowing that disclosure of that 12

material is prohibited by subsection (a), 13

willfully discloses the material in any man-14

ner to any person not entitled to receive 15

that material. 16

‘‘(2) OTHER LAWS.—Section 1905 of title 18, 17

United States Code, shall not apply with respect to 18

the publishing, divulging, disclosure, making known 19

of, or making available, information reported or oth-20

erwise obtained under this Act. 21

‘‘(3) CONTRACTORS.—For purposes of this sub-22

section, any contractor of the United States that is 23

provided information in accordance with subsection 24

(e)(2), including any employee of that contractor, 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

136

•S 697 RS

shall be considered to be an employee of the United 1

States. 2

‘‘(i) APPLICABILITY.— 3

‘‘(1) IN GENERAL.—Except as otherwise pro-4

vided in this section, section 8, or any other applica-5

ble Federal law, the Administrator shall have no au-6

thority— 7

‘‘(A) to require the substantiation or re-8

substantiation of a claim for the protection 9

from disclosure of information submitted to the 10

Administrator under this Act before the date of 11

enactment of the Frank R. Lautenberg Chem-12

ical Safety for the 21st Century Act; or 13

‘‘(B) to impose substantiation or re-14

substantiation requirements under this Act that 15

are more extensive than those required under 16

this section. 17

‘‘(2) PRIOR ACTIONS.—Nothing in this Act pre-18

vents the Administrator from reviewing, requiring 19

substantiation or resubstantiation for, or approving, 20

modifying or denying any claim for the protection 21

from disclosure of information before the effective 22

date of such rules applicable to those claims as the 23

Administrator may promulgate after the date of en-24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

137

•S 697 RS

actment of the Frank R. Lautenberg Chemical Safe-1

ty for the 21st Century Act.’’. 2

SEC. 16. PROHIBITED ACTS. 3


U.S.C. 2614) is amended by striking paragraph (1) and 5


‘‘(1) fail or refuse to comply with— 7

‘‘(A) any rule promulgated, consent agree-8

ment entered into, or order issued under section 9

4; 10

‘‘(B) any requirement under section 5 or 6; 11

‘‘(C) any rule promulgated, consent agree-12


5 or 6; or 14

‘‘(D) any requirement of, or any rule pro-15

mulgated or order issued pursuant to title II;’’. 16

SEC. 17. PENALTIES. 17



(1) in subsection (a)(1)— 20

(A) in the first sentence— 21

(i) by inserting ‘‘this Act or a rule or 22

order promulgated or issued pursuant to 23

this Act, including’’ after ‘‘a provision of’’; 24

and 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

138

•S 697 RS

(ii) by striking ‘‘$25,000’’ and insert-1

ing ‘‘$37,500’’; and 2

(B) in the second sentence, by striking‘‘ 3

violation of section 15 or 409’’ and inserting 4

‘‘violation of this Act’’; and 5

(2) in subsection (b)— 6

(A) by striking ‘‘Any person who’’ and in-7

serting the following: 8

‘‘(1) IN GENERAL.—Any person that’’; 9

(B) by striking ‘‘section 15 or 409’’ and 10

inserting ‘‘this Act’’; 11

(C) by striking ‘‘$25,000’’ and inserting 12

‘‘$50,000’’; and 13

(D) by adding at the end the following: 14

‘‘(2) IMMINENT DANGER OF DEATH OR SERIOUS 15

BODILY INJURY.— 16

‘‘(A) IN GENERAL.—Any person that 17

knowingly or willfully violates any provision of 18

this Act, and that knows at the time of the vio-19

lation that the violation places an individual in 20

imminent danger of death or serious bodily in-21

jury, shall be subject on conviction to a fine of 22

not more than $250,000, or imprisonment for 23

not more than 15 years, or both. 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

139

•S 697 RS

‘‘(B) ORGANIZATIONS.—An organization 1

that commits a violation described in subpara-2

graph (A) shall be subject on conviction to a 3

fine of not more than $1,000,000 for each vio-4

lation. 5

‘‘(3) KNOWLEDGE OF IMMINENT DANGER OR 6

INJURY.—For purposes of determining whether a 7

defendant knew that the violation placed another in-8

dividual in imminent danger of death or serious bod-9

ily injury— 10

‘‘(A) the defendant shall be responsible 11

only for actual awareness or actual belief pos-12

sessed; and 13

‘‘(B) knowledge possessed by an individual 14

may not be attributed to the defendant.’’. 15

SEC. 18. STATE-FEDERAL RELATIONSHIP. 16


U.S.C. 2617) is amended by striking subsections (a) and 18

(b) and inserting the following: 19

‘‘(a) IN GENERAL.— 20

‘‘(1) ESTABLISHMENT OR ENFORCEMENT.—Ex-21

cept as provided in subsections (c), (d), (e), (f), and 22

(g), and subject to paragraph (2), no State or polit-23

ical subdivision of a State may establish or continue 24

to enforce any of the following: 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

140

•S 697 RS

‘‘(A) TESTING AND INFORMATION COLLEC-1

TION.—A statute or administrative action to re-2

quire the development of information on a 3

chemical substance or category of substances 4

that is reasonably likely to produce the same in-5

formation required under section 4, 5, or 6 in— 6

‘‘(i) a rule promulgated by the Admin-7

istrator; 8

‘‘(ii) a testing consent agreement en-9

tered into by the Administrator; or 10

‘‘(iii) an order issued by the Adminis-11

trator. 12

‘‘(B) CHEMICAL SUBSTANCES FOUND TO 13

MEET THE SAFETY STANDARD OR RE-14

STRICTED.—A statute or administrative action 15

to prohibit or otherwise restrict the manufac-16

ture, processing, or distribution in commerce or 17

use of a chemical substance— 18

‘‘(i) found to meet the safety standard 19

and consistent with the scope of the deter-20

mination made under section 6; or 21

‘‘(ii) found not to meet the safety 22

standard, after the effective date of the 23

rule issued under section 6(d) for the sub-24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

141

•S 697 RS

stance, consistent with the scope of the de-1

termination made by the Administrator. 2

‘‘(C) SIGNIFICANT NEW USE.—A statute or 3

administrative action requiring the notification 4

of a use of a chemical substance that the Ad-5

ministrator has specified as a significant new 6

use and for which the Administrator has re-7

quired notification pursuant to a rule promul-8

gated under section 5. 9

‘‘(2) EFFECTIVE DATE OF PREEMPTION.— 10

Under this subsection, Federal preemption of State 11

statutes and administrative actions applicable to spe-12

cific substances shall not occur until the effective 13

date of the applicable action described in paragraph 14

(1) taken by the Administrator. 15

‘‘(b) NEW STATUTES OR ADMINISTRATIVE ACTIONS 16

CREATING PROHIBITIONS OR OTHER RESTRICTIONS.— 17

Except as provided in subsections (c), (d), and (e), no 18

State or political subdivision of a State may establish 19

(after the date of enactment of the Frank R. Lautenberg 20

Chemical Safety for the 21st Century Act) a statute or 21

administrative action prohibiting or restricting the manu-22

facture, processing, distribution in commerce or use of a 23

chemical substance that is a high-priority substance des-24

ignated under section 4A, as of the date on which the Ad-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

142

•S 697 RS

ministrator commences a safety assessment under section 1

6. 2

‘‘(c) SCOPE OF PREEMPTION.—Federal preemption 3

under subsections (a) and (b) of State statutes and admin-4

istrative actions applicable to specific substances shall 5

apply only to— 6

‘‘(1) the chemical substances or category of 7

substances subject to a rule, order, or consent agree-8

ment under section 4; 9

‘‘(2) the uses or conditions of use of such sub-10

stances that are identified by the Administrator as 11

subject to review in a safety assessment and in-12

cluded in the scope of the safety determination made 13

by the Administrator for the substance, or of any 14

rule the Administrator promulgates pursuant to sec-15

tion 6(d); or 16

‘‘(3) the uses of such substances that the Ad-17

ministrator has specified as significant new uses and 18

for which the Administrator has required notifica-19

tion pursuant to a rule promulgated under section 5. 20

‘‘(d) EXCEPTIONS.— 21

‘‘(1) IN GENERAL.—Subsections (a) and (b) 22

shall not apply to a statute or administrative action 23

of a State or a political subdivision of a State appli-24

cable to a specific chemical substance that— 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

143

•S 697 RS

‘‘(A) is adopted under the authority of, or 1

authorized to comply with, any other Federal 2

law; 3

‘‘(B) implements a reporting, monitoring, 4

or other information collection obligation for 5

the chemical substance not otherwise required 6

by the Administrator under this Act or required 7

under any other Federal law; or 8

‘‘(C) is adopted pursuant to authority 9

under a law of the State or political subdivision 10

of the State related to water quality, air qual-11

ity, or waste treatment or disposal, unless the 12

action taken by the State or political subdivi-13

sion of a State— 14

‘‘(i) imposes a restriction on the man-15

ufacture, processing, distribution in com-16

merce, or use of a chemical substance; and 17

‘‘(ii)(I) is already required by a deci-18

sion by the Administrator under section 5 19

or 6; 20

‘‘(II) is taken to address a health or 21

environmental concern that applies to the 22

uses or conditions of use that are included 23

in the scope of a safety determination pur-24

suant to section 6 or the scope of a signifi-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

144

•S 697 RS

cant new use rule promulgated pursuant to 1

section 5, but is inconsistent with the ac-2

tion of the Administrator; or 3

‘‘(III) would cause a violation of the 4

applicable action by the Administrator 5

under section 5 or 6. 6

‘‘(2) NO PREEMPTION OF STATE STATUTES 7

AND ADMINISTRATIVE ACTIONS.—Nothing in this 8

Act, nor any amendment made by this Act, nor any 9

rule, standard of performance, safety determination, 10

or scientific assessment implemented pursuant to 11

this Act, shall affect the right of a State or a polit-12

ical subdivision of a State to adopt or enforce any 13

rule, standard of performance, safety determination, 14

scientific assessment, or any protection for public 15

health or the environment that— 16

‘‘(A) is adopted under the authority of, or 17

authorized to comply with, any other Federal 18

law; 19

‘‘(B) implements a reporting, monitoring, 20

or other information collection obligation for 21

the chemical substance not otherwise required 22

by the Administrator under this Act or required 23

under any other Federal law; or 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

145

•S 697 RS

‘‘(C) is adopted pursuant to authority 1

under a law of the State or political subdivision 2

of the State related to water quality, air qual-3

ity, or waste treatment or disposal, unless the 4

action taken by the State or political subdivi-5

sion of a State— 6

‘‘(i) imposes a restriction on the man-7

ufacture, processing, distribution in com-8

merce, or use of a chemical substance; and 9

‘‘(ii)(I) is already required by a deci-10

sion by the Administrator under section 5 11

or 6; 12

‘‘(II) is taken to address a health or 13

environmental concern that applies to the 14

uses or conditions of use that are included 15

in the scope of a safety determination pur-16

suant to section 6 or the scope of a signifi-17

cant new use rule promulgated pursuant to 18

section 5, but is inconsistent with the ac-19

tion of the Administrator; or 20

‘‘(III) would cause a violation of the 21

applicable action by the Administrator 22

under section 5 or 6. 23

‘‘(3) APPLICABILITY TO CERTAIN RULES OR OR-24

DERS.—Notwithstanding subsection (e)— 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

146

•S 697 RS

‘‘(A) nothing in this section shall be con-1

strued as modifying the effect under this sec-2

tion, as in effect on the day before the effective 3

date of the Frank R. Lautenberg Chemical 4

Safety for the 21st Century Act, of any rule or 5

order promulgated or issued under this Act 6

prior to that effective date; and 7

‘‘(B) with respect to a chemical substance 8

or mixture for which any rule or order was pro-9

mulgated or issued under section 6 prior to the 10

effective date of the Frank R. Lautenberg 11

Chemical Safety for the 21st Century Act with 12

regards to manufacturing, processing, distribu-13

tion in commerce, use, or disposal of a chemical 14

substance, this section (as in effect on the day 15

before the effective date of the Frank R. Lau-16

tenberg Chemical Safety for the 21st Century 17

Act) shall govern the preemptive effect of any 18

rule or order that is promulgated or issued re-19

specting such chemical substance or mixture 20

under section 6 of this Act after that effective 21

date, unless the latter rule or order is with re-22

spect to a chemical substance or mixture con-23

taining a chemical substance and follows a des-24

ignation of that chemical substance as a high- 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

147

•S 697 RS

priority substance under subsection (b) or (c) of 1

section 4A or as an additional priority for safe-2

ty assessment and safety determination under 3

section 4A(d). 4

‘‘(e) PRESERVATION OF CERTAIN STATE LAW.— 5

‘‘(1) IN GENERAL.—Nothing in this Act, sub-6

ject to subsection (g) of this section, shall— 7

‘‘(A) be construed to preempt or otherwise 8

affect any action taken before January 1, 2015, 9

under the authority of a State law that pro-10

hibits or otherwise restricts manufacturing, 11

processing, distribution in commerce, use, or 12

disposal of a chemical substance; or 13

‘‘(B) be construed to preempt or otherwise 14

affect any action taken pursuant to a State law 15

that was in effect on August 31, 2003. 16

‘‘(2) EFFECT OF SUBSECTION.—This sub-17

section does not affect, modify, or alter the relation-18

ship between State and Federal law pursuant to any 19

other Federal law. 20

‘‘(f) STATE WAIVERS.— 21

‘‘(1) IN GENERAL.—Upon application of a State 22

or political subdivision of a State, the Administrator 23

may— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

148

•S 697 RS

‘‘(A) by rule, exempt from subsection (a), 1

under such conditions as may be prescribed in 2

the rule, a statute or administrative action of 3

that State or political subdivision of the State 4

that relates to the effects of, or exposure to, a 5

chemical substance under the conditions of use 6

if the Administrator determines that— 7

‘‘(i) compelling State or local condi-8

tions warrant granting the waiver to pro-9

tect health or the environment; 10

‘‘(ii) compliance with the proposed re-11

quirement of the State or political subdivi-12

sion of the State would not unduly burden 13

interstate commerce in the manufacture, 14

processing, distribution in commerce, or 15

use of a chemical substance; 16

‘‘(iii) compliance with the proposed re-17

quirement of the State or political subdivi-18

sion of the State would not cause a viola-19

tion of any applicable Federal law, rule, or 20

order; and 21

‘‘(iv) based on the judgment of the 22

Administrator, the proposed requirement 23

of the State or political subdivision of the 24

State is consistent with sound objective sci-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

149

•S 697 RS

entific practices, the weight of the evi-1

dence, and the best available science; or 2

‘‘(B) exempt from subsection (b) a statute 3

or administrative action of a State or political 4

subdivision of a State that relates to the effects 5

of exposure to a chemical substance under the 6

conditions of use if the Administrator deter-7

mines that— 8

‘‘(i) the State has a compelling local 9

interest that warrants granting the waiver 10

to protect health or the environment; 11

‘‘(ii) compliance with the proposed re-12

quirement of the State will not unduly bur-13

den interstate commerce in the manufac-14

ture, processing, distribution in commerce, 15

or use of a chemical substance; 16

‘‘(iii) compliance with the proposed re-17

quirement would not cause a violation of 18

any applicable Federal law, rule, or order; 19

and 20

‘‘(iv) the proposed requirement is 21

grounded in reasonable scientific concern. 22

‘‘(2) APPROVAL OF A STATE WAIVER RE-23

QUEST.—The Administrator shall grant or deny a 24

waiver application— 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

150

•S 697 RS

‘‘(A) not later than 180 days after the date 1

on which an application under paragraph (1)(A) 2

is submitted; and 3

‘‘(B) not later than 90 days after the date 4

on which an application under paragraph 5

(1)(B) is submitted. 6

‘‘(3) NOTICE AND COMMENT.—The application 7

of a State or political subdivision of the State shall 8

be subject to public notice and comment. 9

‘‘(4) FINAL AGENCY ACTION.—The decision of 10

the Administrator on the application of a State or 11

political subdivision of the State shall be— 12

‘‘(A) considered to be a final agency ac-13

tion; and 14

‘‘(B) subject to judicial review. 15

‘‘(5) DURATION OF WAIVERS.—A waiver grant-16

ed under paragraph (1)(B) shall remain in effect 17

until the later of— 18

‘‘(A) such time as the safety assessment 19

and safety determination is completed; and 20

‘‘(B) the date on which compliance with an 21

applicable rule issued under section 6(d) is re-22

quired. 23

‘‘(6) JUDICIAL REVIEW OF WAIVERS.—Not later 24

than 60 days after the date on which the Adminis-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

151

•S 697 RS

trator makes a determination on an application of a 1

State or political subdivision of the State under sub-2

paragraph (A) or (B) of paragraph (1), any person 3

may file a petition for judicial review in the United 4

States Court of Appeals for the District of Columbia 5

Circuit, which shall have exclusive jurisdiction over 6

the determination. 7

‘‘(7) JUDICIAL REVIEW OF PRIORITIZATION 8

SCREENING DECISION.—Not later than 60 days after 9

the date on which the Administrator makes a deci-10

sion on a recommendation made under section 11

4A(b)(4) to designate a chemical substance as a low 12

priority, the Governor of a State or a State agency 13

with responsibility for protecting health and the en-14

vironment that submitted the recommendation under 15

section 4A(a)(4)(A), as applicable, may file a peti-16

tion for judicial review in the United States Court 17

of Appeals for the District of Columbia Circuit, 18

which shall have exclusive jurisdiction over the deter-19

mination. 20

‘‘(g) SAVINGS.— 21

‘‘(1) NO PREEMPTION OF COMMON LAW OR 22

STATUTORY CAUSES OF ACTION FOR CIVIL RELIEF 23

OR CRIMINAL CONDUCT.— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

152

•S 697 RS

‘‘(A) IN GENERAL.—Nothing in this Act, 1

nor any amendment made by this Act, nor any 2

safety standard, rule, requirement, standard of 3

performance, safety determination, or scientific 4

assessment implemented pursuant to this Act, 5

shall be construed to preempt, displace, or sup-6

plant any state or Federal common law rights 7

or any state or Federal statute creating a rem-8

edy for civil relief, including those for civil dam-9

age, or a penalty for a criminal conduct. 10

‘‘(B) CLARIFICATION OF NO PREEMP-11

TION.—Notwithstanding any other provision of 12

this Act, nothing in this Act, nor any amend-13

ments made by this Act, shall preempt or pre-14

clude any cause of action for personal injury, 15

wrongful death, property damage, or other in-16

jury based on negligence, strict liability, prod-17

ucts liability, failure to warn, or any other legal 18

theory of liability under any State law, mari-19

time law, or Federal common law or statutory 20

theory. 21

‘‘(2) NO EFFECT ON PRIVATE REMEDIES.— 22

‘‘(A) Nothing in this Act, nor any amend-23

ments made by this Act, nor any rules, regula-24

tions, requirements, safety assessments, safety 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

153

•S 697 RS

determinations, scientific assessments, or orders 1

issued pursuant to this Act shall be interpreted 2

as, in either the plaintiff’s or defendant’s favor, 3

dispositive in any civil action. 4

‘‘(B) This Act does not affect the authority 5

of any court to make a determination in an ad-6

judicatory proceeding under applicable State or 7

Federal law with respect to the admission into 8

evidence or any other use of this Act or rules, 9

regulations, requirements, standards of per-10

formance, safety assessments, scientific assess-11

ments, or orders issued pursuant to this Act.’’. 12

SEC. 19. JUDICIAL REVIEW. 13




(A) in paragraph (1)— 17

(i) in subparagraph (A), by striking 18

‘‘section 4(a), 5(a)(2), 5(b)(4), 6(a), 6(e), 19

or 8, or under title II or IV’’ and inserting 20

‘‘section 4(a), 5(d), 6(c), 6(d), 6(g), or 8, 21

or title II or IV’’; and 22

(ii) in subparagraph (B), by striking 23

‘‘an order issued under subparagraph (A) 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

154

•S 697 RS

or (B) of section 6(b)(1)’’ and inserting 1

‘‘an order issued under this title’’; and 2

(B) in paragraph (2), in the first sentence, 3

by striking ‘‘paragraph (1)(A)’’ and inserting 4

‘‘paragraph (1)’’; and 5

(C) by striking paragraph (3); and 6

(2) in subsection (c)(1)(B)— 7

(A) in clause (i)— 8

(i) by striking ‘‘section 4(a), 5(b)(4), 9

6(a), or 6(e)’’ and inserting ‘‘section 4(a), 10

5(d), 6(d), or 6(g)’’; and 11

(ii) by striking ‘‘evidence in the rule-12

making record (as defined in subsection 13

(a)(3)) taken as a whole;’’ and inserting 14

‘‘evidence (including any matter) in the 15

rulemaking record, taken as a whole; and’’; 16

and 17

(B) by striking clauses (ii) and (iii) and 18

the matter following clause (iii) and inserting 19

the following: 20

‘‘(ii) the court may not review the 21

contents and adequacy of any statement of 22

basis and purpose required by section 23

553(c) of title 5, United States Code, to be 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

155

•S 697 RS

incorporated in the rule, except as part of 1

the rulemaking record, taken as a whole.’’. 2

SEC. 20. CITIZENS’ PETITIONS. 3



(1) in subsection (a), by striking ‘‘an order 6

under section 5(e) or 6(b)(2)’’ and inserting ‘‘an 7

order under section 4 or 5(d)’’; and 8


(A) in paragraph (1), by striking ‘‘an 10

order under section 5(e), 6(b)(1)(A), or 11

6(b)(1)(B)’’ and inserting ‘‘an order under sec-12

tion 4 or 5(d)’’; and 13

(B) in paragraph (4), by striking subpara-14

graph (B) and inserting the following: 15

‘‘(B) DE NOVO PROCEEDING.— 16

‘‘(i) IN GENERAL.—In an action 17

under subparagraph (A) to initiate a pro-18

ceeding to promulgate a rule pursuant to 19

section 4, 5, 6, or 8 or an order issued 20

under section 4 or 5, the petitioner shall be 21

provided an opportunity to have the peti-22

tion considered by the court in a de novo 23

proceeding. 24

‘‘(ii) DEMONSTRATION.— 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

156

•S 697 RS

‘‘(I) IN GENERAL.—The court in 1

a de novo proceeding under this sub-2

paragraph shall order the Adminis-3

trator to initiate the action requested 4

by the petitioner if the petitioner dem-5

onstrates to the satisfaction of the 6

court by a preponderance of the evi-7

dence that— 8

‘‘(aa) in the case of a peti-9

tion to initiate a proceeding for 10

the issuance of a rule or order 11

under section 4, the information 12

available to the Administrator is 13

insufficient for the Administrator 14

to perform an action described in 15

section 4, 4A, 5, or 6(d); 16

‘‘(bb) in the case of a peti-17

tion to issue an order under sec-18

tion 5(d), there is a reasonable 19

basis to conclude that the chem-20

ical substance is not likely to 21

meet the safety standard; 22

‘‘(cc) in the case of a peti-23


the issuance of a rule under sec-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

157

•S 697 RS

tion 6(d), there is a reasonable 1

basis to conclude that the chem-2

ical substance will not meet the 3

safety standard; or 4

‘‘(dd) in the case of a peti-5



tion 8, there is a reasonable basis 8

to conclude that the rule is nec-9

essary to protect health or the 10

environment or ensure that the 11

chemical substance meets the 12

safety standard. 13

‘‘(II) DEFERMENT.—The court 14

in a de novo proceeding under this 15

subparagraph may permit the Admin-16

istrator to defer initiating the action 17

requested by the petitioner until such 18

time as the court prescribes, if the 19

court finds that— 20

‘‘(aa) the extent of the risk 21

to health or the environment al-22

leged by the petitioner is less 23

than the extent of risks to health 24

or the environment with respect 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

158

•S 697 RS

to which the Administrator is 1

taking action under this Act; and 2

‘‘(bb) there are insufficient 3

resources available to the Admin-4

istrator to take the action re-5

quested by the petitioner.’’. 6

SEC. 21. EMPLOYMENT EFFECTS. 7

Section 24(b)(2)(B)(ii) of the Toxic Substances Con-8

trol Act (15 U.S.C. 2623(b)(2)(B)(ii)) is amended by 9

striking ‘‘section 6(c)(3),’’ and inserting ‘‘the applicable 10

requirements of this Act;’’. 11

SEC. 22. STUDIES. 12


U.S.C. 2624) is repealed. 14

SEC. 23. ADMINISTRATION. 15




following: 19

‘‘(b) FEES.— 20


tablish, not later than 1 year after the date of enact-22

ment of the Frank R. Lautenberg Chemical Safety 23

for the 21st Century Act, by rule— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

159

•S 697 RS

‘‘(A) the payment of 1 or more reasonable 1

fees as a condition of submitting a notice or re-2

questing an exemption under section 5; and 3

‘‘(B) the payment of 1 or more reasonable 4

fees by a manufacturer or processor that— 5

‘‘(i) is required to submit a notice 6

pursuant to the rule promulgated under 7

section 8(b)(4)(A)(i) identifying a chemical 8

substance as active; 9

‘‘(ii) is required to submit a notice 10

pursuant to section 8(b)(5)(B)(i) changing 11

the status of a chemical substance from in-12

active to active; 13

‘‘(iii) is required to report information 14

pursuant to the rules promulgated under 15

section 8(a)(4); and 16

‘‘(iv) manufactures or processes a 17

chemical substance subject to a safety as-18

sessment and safety determination pursu-19

ant to section 6. 20

‘‘(2) UTILIZATION AND COLLECTION OF 21

FEES.—The Administrator shall— 22

‘‘(A) utilize the fees collected under para-23

graph (1) only to defray costs associated with 24

the actions of the Administrator— 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

160

•S 697 RS

‘‘(i) to collect, process, review, provide 1

access to, and protect from disclosure 2

(where appropriate) information on chem-3

ical substances under this Act; 4

‘‘(ii) to review notices and make de-5

terminations for chemical substances under 6

paragraphs (1) and (3) of section 5(d) and 7

impose any necessary restrictions under 8

section 5(d)(4); 9

‘‘(iii) to make prioritization decisions 10

under section 4A; 11

‘‘(iv) to conduct and complete safety 12

assessments and determinations under sec-13

tion 6; and 14

‘‘(v) to conduct any necessary rule-15

making pursuant to section 6(d); 16

‘‘(B) insofar as possible, collect the fees 17

described in paragraph (1) in advance of con-18

ducting any fee-supported activity; 19

‘‘(C) deposit the fees in the Fund estab-20

lished by paragraph (4)(A); and 21

‘‘(D) not collect excess fees or retain a sig-22

nificant amount of unused fees. 23


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

161

•S 697 RS

‘‘(3) AMOUNT AND ADJUSTMENT OF FEES; RE-1

FUNDS.—In setting fees under this section, the Ad-2

ministrator shall— 3

‘‘(A) take into account the cost to the Ad-4

ministrator of conducting the activities de-5

scribed in paragraph (2); 6

‘‘(B) prescribe lower fees for small busi-7

ness concerns, after consultation with the Ad-8

ministrator of the Small Business Administra-9

tion; 10

‘‘(C) set the fees established under para-11

graph (1) at levels such that the fees will, in 12

aggregate, provide a sustainable source of funds 13

to defray approximately 25 percent of the costs 14

of conducting the activities identified in para-15

graph (2)(A), not to exceed $18,000,000, not 16

including fees under subparagraph (E) of this 17

paragraph; 18

‘‘(D) reflect an appropriate balance in the 19

assessment of fees between manufacturers and 20

processors, and allow the payment of fees by 21

consortia of manufacturers or processors; 22

‘‘(E) for substances designated as addi-23

tional priorities pursuant to section 4A(c), es-24

tablish the fee at a level sufficient to defray the 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

162

•S 697 RS

full costs to the Administrator of conducting 1

the safety assessment and safety determination 2

under section 6; 3

‘‘(F) prior to the establishment or amend-4

ment of any fees under paragraph (1), consult 5

and meet with parties potentially subject to the 6

fees or their representatives, subject to the con-7

dition that no obligation under the Federal Ad-8

visory Committee Act (5 U.S.C. App.) or sub-9

chapter III of chapter 5 of title 5, United 10

States Code, is applicable with respect to such 11

meetings; 12

‘‘(G) beginning with the fiscal year that is 13

3 years after the date of enactment of the 14

Frank R. Lautenberg Chemical Safety for the 15

21st Century Act, and every 3 years thereafter, 16

after consultation with parties potentially sub-17

ject to the fees and their representatives, in-18

crease or decrease the fees established under 19

paragraph (1) as necessary— 20

‘‘(i) to ensure that funds deposited in 21

the Fund are sufficient to conduct the ac-22

tivities identified in paragraph (2)(A) and 23

the full costs of safety assessments and 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

163

•S 697 RS

safety determinations pursuant to subpara-1

graph (E); and 2

‘‘(ii) to account for inflation; 3

‘‘(H) adjust fees established under para-4

graph (1) as necessary to vary on account of 5

differing circumstances, including reduced fees 6

or waivers in appropriate circumstances, to re-7

duce the burden on manufacturing or proc-8

essing, remove barriers to innovation, or where 9

the costs to the Administrator of collecting the 10

fees exceed the fee revenue anticipated to be 11

collected; and 12

‘‘(I) if a notice submitted under section 5 13

is refused or subsequently withdrawn, refund 14

the fee or a portion of the fee if no substantial 15

work was performed on the notice. 16

‘‘(4) TSCA IMPLEMENTATION FUND.— 17

‘‘(A) ESTABLISHMENT.—There is estab-18

lished in the Treasury of the United States a 19

fund, to be known as the ‘TSCA Implementa-20

tion Fund’ (referred to in this subsection as the 21

‘Fund’), consisting of— 22

‘‘(i) such amounts as are deposited in 23

the Fund under paragraph (2)(C); and 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

164

•S 697 RS

‘‘(ii) any interest earned on the in-1

vestment of amounts in the Fund; and 2

‘‘(iii) any proceeds from the sale or 3

redemption of investments held in the 4

Fund. 5

‘‘(B) CREDITING AND AVAILABILITY OF 6

FEES.— 7

‘‘(i) IN GENERAL.—Fees authorized 8

under this section shall be collected and 9

available for obligation only to the extent 10

and in the amount provided in advance in 11

appropriations Acts, and shall be available 12

without fiscal year limitation. 13

‘‘(ii) REQUIREMENTS.—Fees collected 14

under this section shall not— 15

‘‘(I) be made available or obli-16

gated for any purpose other than to 17

defray the costs of conducting the ac-18

tivities identified in paragraph (2)(A); 19

‘‘(II) otherwise be available for 20

any purpose other than implementa-21

tion of this Act; and 22

‘‘(III) so long as amounts in the 23

Fund remain available, be subject to 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

165

•S 697 RS

restrictions on expenditures applicable 1

to the Federal government as a whole. 2

‘‘(C) UNUSED FUNDS.—Amounts in the 3

Fund not currently needed to carry out this 4

subsection shall be— 5

‘‘(i) maintained readily available or on 6

deposit; 7

‘‘(ii) invested in obligations of the 8

United States or guaranteed by the United 9

States; or 10

‘‘(iii) invested in obligations, partici-11

pations, or other instruments that are law-12

ful investments for fiduciary, trust, or pub-13

lic funds. 14

‘‘(D) MINIMUM AMOUNT OF APPROPRIA-15

TIONS.—Fees may not be assessed for a fiscal 16

year under this section unless the amount of 17

appropriations for salaries, contracts, and ex-18

penses for the functions (as in existence in fis-19

cal year 2015) of the Office of Pollution Pre-20

vention and Toxics of the Environmental Pro-21

tection Agency for the fiscal year (excluding the 22

amount of any fees appropriated for the fiscal 23

year) are equal to or greater than the amount 24

of appropriations for covered functions for fiscal 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

166

•S 697 RS

year 2015 (excluding the amount of any fees 1

appropriated for the fiscal year). 2

‘‘(5) AUDITING.— 3

‘‘(A) FINANCIAL STATEMENTS OF AGEN-4

CIES.—For the purpose of section 3515(c) of 5

title 31, United States Code, the Fund shall be 6

considered a component of an executive agency. 7

‘‘(B) COMPONENTS.—The annual audit re-8

quired under sections 3515(b) and 3521 of that 9

title of the financial statements of activities 10

under this subsection shall include an analysis 11

of— 12

‘‘(i) the fees collected under para-13

graph (1) and disbursed; 14

‘‘(ii) compliance with the deadlines es-15

tablished in section 6 of this Act; 16

‘‘(iii) the amounts budgeted, appro-17

priated, collected from fees, and disbursed 18

to meet the requirements of sections 4, 4A, 19

5, 6, 8, and 14, including the allocation of 20

full time equivalent employees to each such 21

section or activity; and 22

‘‘(iv) the reasonableness of the alloca-23

tion of the overhead associated with the 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

167

•S 697 RS

conduct of the activities described in para-1

graph (2)(A). 2

‘‘(C) INSPECTOR GENERAL.—The Inspec-3

tor General of the Environmental Protection 4

Agency shall— 5

‘‘(i) conduct the annual audit required 6

under this subsection; and 7

‘‘(ii) report the findings and rec-8

ommendations of the audit to the Adminis-9

trator and to the appropriate committees 10

of Congress. 11

‘‘(6) TERMINATION.—The authority provided by 12

this section shall terminate at the conclusion of the 13

fiscal year that is 10 years after the date of enact-14

ment of the Frank R. Lautenberg Chemical Safety 15

for the 21st Century Act, unless otherwise reauthor-16

ized or modified by Congress.’’; 17

(2) in subsection (e), by striking ‘‘Health, Edu-18

cation, and Welfare’’ each place it appears and in-19


(3) adding at the end the following: 21

‘‘(h) PRIOR ACTIONS.—Nothing in this Act elimi-22

nates, modifies, or withdraws any rule promulgated, order 23

issued, or exemption established pursuant to this Act be-24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

168

•S 697 RS

fore the date of enactment of the Frank R. Lautenberg 1

Chemical Safety for the 21st Century Act.’’. 2

SEC. 24. DEVELOPMENT AND EVALUATION OF TEST METH-3

ODS AND SUSTAINABLE CHEMISTRY. 4



(1) in subsection (a), in the first sentence by 7




‘‘(c) SUSTAINABLE CHEMISTRY PROGRAM.—The 11

President shall establish an interagency Sustainable 12

Chemistry Program to promote and coordinate Federal 13

sustainable chemistry research, development, demonstra-14

tion, technology transfer, commercialization, education, 15

and training activities. 16

‘‘(d) PROGRAM ACTIVITIES.—The activities of the 17

Program shall be designed to— 18

‘‘(1) provide sustained support for sustainable 19

chemistry research, development, demonstration, 20

technology transfer, commercialization, education, 21

and training through— 22

‘‘(A) coordination of sustainable chemistry 23

research, development, demonstration, and tech-24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

169

•S 697 RS

nology transfer conducted at Federal labora-1

tories and agencies; and 2

‘‘(B) to the extent practicable, encourage-3

ment of consideration of sustainable chemistry 4

in, as appropriate— 5

‘‘(i) the conduct of Federal and State 6

science and engineering research and de-7

velopment; and 8

‘‘(ii) the solicitation and evaluation of 9

applicable proposals for science and engi-10

neering research and development; 11

‘‘(2) examine methods by which the Federal 12

Government can create incentives for consideration 13

and use of sustainable chemistry processes and prod-14

ucts, including innovative financing mechanisms; 15

‘‘(3) expand the education and training of un-16

dergraduate and graduate students and professional 17

scientists and engineers, including through partner-18

ships with industry, in sustainable chemistry science 19

and engineering; 20

‘‘(4) collect and disseminate information on sus-21

tainable chemistry research, development, and tech-22

nology transfer including information on— 23

‘‘(A) incentives and impediments to devel-24

opment, manufacturing, and commercialization; 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

170

•S 697 RS

‘‘(B) accomplishments; 1

‘‘(C) best practices; and 2

‘‘(D) costs and benefits; and 3

‘‘(5) support (including through technical as-4

sistance, participation, financial support, or other 5

forms of support) economic, legal, and other appro-6

priate social science research to identify barriers to 7

commercialization and methods to advance commer-8

cialization of sustainable chemistry. 9

‘‘(e) INTERAGENCY WORKING GROUP.— 10

‘‘(1) ESTABLISHMENT.—Not later than 180 11

days after the date of enactment of the Frank R. 12

Lautenberg Chemical Safety for the 21st Century 13

Act, the President, in consultation with the Office of 14

Science and Technology Policy, shall establish an 15

Interagency Working Group that shall include rep-16

resentatives from the National Science Foundation, 17

the National Institute of Standards and Technology, 18

the Department of Energy, the Environmental Pro-19

tection Agency, the Department of Agriculture, the 20

Department of Defense, the National Institutes of 21

Health, and any other agency that the President 22

may designate to oversee the planning, management, 23

and coordination of the Program. 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

171

•S 697 RS

‘‘(2) GOVERNANCE.—The Director of the Na-1

tional Science Foundation and the Assistant Admin-2

istrator for Research and Development of the Envi-3

ronmental Protection Agency, or their designees, 4

shall serve as co-chairs of the Interagency Working 5

Group. 6

‘‘(3) RESPONSIBILITIES.—In overseeing the 7

planning, management, and coordination of the Pro-8

gram, the Interagency Working Group shall— 9

‘‘(A) establish goals and priorities for the 10

Program, in consultation with the Advisory 11

Council; 12

‘‘(B) provide for interagency coordination, 13

including budget coordination, of activities 14

under the Program; 15

‘‘(C) meet not later than 90 days from its 16

establishment and periodically thereafter; and 17

‘‘(D) establish and consult with an Advi-18

sory Council on a regular basis. 19

‘‘(4) MEMBERSHIP.—The Advisory Council 20

members shall not be employees of the Federal Gov-21

ernment and shall include a diverse representation of 22

knowledgeable individuals from the private sector 23

(including small- and medium-sized enterprises from 24

across the value chain), academia, State and tribal 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

172

•S 697 RS

governments, and nongovernmental organizations 1

and others who are in a position to provide exper-2

tise. 3

‘‘(f) AGENCY BUDGET REQUESTS.— 4

‘‘(1) IN GENERAL.—Each Federal agency and 5

department participating in the Program shall, as 6

part of its annual request for appropriations to the 7

Office of Management and Budget, submit a report 8

to the Office of Management and Budget that— 9

‘‘(A) identifies the activities of the agency 10

or department that contribute directly to the 11

Program; and 12

‘‘(B) states the portion of the agency or 13

department’s request for appropriations that is 14

allocated to those activities. 15

‘‘(2) ANNUAL BUDGET REQUEST TO CON-16

GRESS.—The President shall include in the annual 17

budget request to Congress a statement of the por-18

tion of the annual budget request for each agency or 19

department that will be allocated to activities under-20

taken pursuant to the Program. 21

‘‘(g) REPORT TO CONGRESS.— 22

‘‘(1) IN GENERAL.—Not later than 2 years 23

after the date of enactment of the Frank R. Lauten-24

berg Chemical Safety for the 21st Century Act, the 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

173

•S 697 RS

Interagency Working Group shall submit a report to 1

the Committee on Science, Space, and Technology 2

and Committee on Energy and Commerce of the 3

House of Representatives and the Committee on En-4

vironment and Public Works and the Committee on 5

Commerce, Science, and Transportation of the Sen-6

ate that shall include— 7

‘‘(A) a summary of federally funded sus-8

tainable chemistry research, development, dem-9

onstration, technology transfer, commercializa-10

tion, education, and training activities; 11

‘‘(B) a summary of the financial resources 12

allocated to sustainable chemistry initiatives; 13

‘‘(C) an analysis of the progress made to-14

ward achieving the goals and priorities of this 15

Act, and recommendations for future program 16

activities; 17

‘‘(D) an assessment of the benefits of ex-18

panding existing, federally supported regional 19

innovation and manufacturing hubs to include 20

sustainable chemistry and the value of directing 21

the creation of 1 or more dedicated sustainable 22

chemistry centers of excellence or hubs; and 23

‘‘(E) an evaluation of steps taken and fu-24

ture strategies to avoid duplication of efforts, 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

174

•S 697 RS

streamline interagency coordination, facilitate 1

information sharing, and spread best practices 2

between participating agencies in the Program. 3

‘‘(2) SUBMISSION TO GAO.—The Interagency 4

Working Group shall also submit the report de-5

scribed in paragraph (1) to the Government Ac-6

countability Office for consideration in future Con-7

gressional inquiries.’’. 8

SEC. 25. STATE PROGRAMS. 9



(1) in subsection (b)(1)— 12

(A) in subparagraphs (A) through (D), by 13

striking the comma at the end of each subpara-14

graph and inserting a semicolon; and 15

(B) in subparagraph (E), by striking ‘‘, 16

and’’ and inserting ‘‘; and’’; and 17

(2) by striking subsections (c) and (d). 18

SEC. 26. AUTHORIZATION OF APPROPRIATIONS. 19



SEC. 27. ANNUAL REPORT. 22





alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

175

•S 697 RS

‘‘(2)(A) the number of notices received during 1

each year under section 5; and 2

‘‘(B) the number of the notices described in 3

subparagraph (A) for chemical substances subject to 4

a rule, testing consent agreement, or order under 5

section 4;’’. 6

SEC. 28. EFFECTIVE DATE. 7


U.S.C. 2601 note; Public Law 94–469) is amended— 9

(1) by striking ‘‘Except as provided in section 10

4(f), this’’ and inserting the following: 11

‘‘(a) IN GENERAL.—This’’; and 12


‘‘(b) RETROACTIVE APPLICABILITY.—Nothing in this 14

Act shall be interpreted to apply retroactively to any State, 15

Federal, or maritime legal action commenced prior to the 16

effective date of the Frank R. Lautenberg Chemical Safety 17

for the 21st Century Act.’’. 18

SECTION 1. SHORT TITLE. 19

This Act may be cited as the ‘‘Frank R. Lautenberg 20

Chemical Safety for the 21st Century Act’’. 21

SEC. 2. FINDINGS, POLICY, AND INTENT. 22

Section 2(c) of the Toxic Substances Control Act (15 23

U.S.C. 2601(c)) is amended— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

176

•S 697 RS

(1) by striking ‘‘It is the intent’’ and inserting 1

the following: 2

‘‘(1) ADMINISTRATION.—It is the intent’’; 3

(2) in paragraph (1) (as so redesignated), by in-4

serting ‘‘, as provided under this Act’’ before the pe-5

riod at the end; and 6


‘‘(2) REFORM.—This Act, including reforms in 8

accordance with the amendments made by the Frank 9

R. Lautenberg Chemical Safety for the 21st Century 10

Act— 11

‘‘(A) shall be administered in a manner 12

that— 13

‘‘(i) protects the health of children, 14

pregnant women, the elderly, workers, con-15

sumers, the general public, and the environ-16

ment from the risks of harmful exposures to 17

chemical substances and mixtures; and 18

‘‘(ii) ensures that appropriate informa-19

tion on chemical substances and mixtures is 20

available to public health officials and first 21

responders in the event of an emergency; 22

and 23

‘‘(B) shall not displace or supplant common 24

law rights of action or remedies for civil relief.’’. 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

177

•S 697 RS

SEC. 3. DEFINITIONS. 1



(1) by redesignating paragraphs (4), (5), (6), 4

(7), (8), (9), (10), (11), (12), (13), and (14) as para-5

graphs (5), (6), (7), (8), (9), (10), (12), (13), (17), 6

(18), and (19), respectively; 7

(2) by inserting after paragraph (3) the fol-8

lowing: 9

‘‘(4) CONDITIONS OF USE.—The term ‘conditions 10

of use’ means the intended, known, or reasonably fore-11

seeable circumstances the Administrator determines a 12

chemical substance is manufactured, processed, dis-13

tributed in commerce, used, or disposed of.’’; 14



‘‘(11) POTENTIALLY EXPOSED OR SUSCEPTIBLE 17

POPULATION.—The term ‘potentially exposed or sus-18

ceptible population’ means 1 or more groups— 19

‘‘(A) of individuals within the general pop-20

ulation who may be— 21

‘‘(i) differentially exposed to chemical 22

substances under the conditions of use; or 23

‘‘(ii) susceptible to greater adverse 24

health consequences from chemical exposures 25

than the general population; and 26


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

178

•S 697 RS

‘‘(B) that when identified by the Adminis-1

trator may include such groups as infants, chil-2

dren, pregnant women, workers, and the elder-3

ly.’’; and 4



‘‘(14) SAFETY ASSESSMENT.—The term ‘safety 7

assessment’ means an assessment of the risk posed by 8

a chemical substance under the conditions of use, in-9

tegrating hazard, use, and exposure information re-10

garding the chemical substance. 11

‘‘(15) SAFETY DETERMINATION.—The term ‘safe-12

ty determination’ means a determination by the Ad-13

ministrator as to whether a chemical substance meets 14

the safety standard under the conditions of use. 15

‘‘(16) SAFETY STANDARD.—The term ‘safety 16

standard’ means a standard that ensures, without 17

taking into consideration cost or other nonrisk fac-18

tors, that no unreasonable risk of injury to health or 19

the environment will result from exposure to a chem-20

ical substance under the conditions of use, including 21

no unreasonable risk of injury to— 22

‘‘(A) the general population; or 23

‘‘(B) any potentially exposed or susceptible 24

population that the Administrator has identified 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

179

•S 697 RS

as relevant to the safety assessment and safety 1

determination for a chemical substance.’’. 2

SEC. 4. POLICIES, PROCEDURES, AND GUIDANCE. 3



‘‘SEC. 3A. POLICIES, PROCEDURES, AND GUIDANCE. 6

‘‘(a) DEFINITION OF GUIDANCE.—In this section, the 7

term ‘guidance’ includes any significant written guidance 8

of general applicability prepared by the Administrator. 9

‘‘(b) DEADLINE.—Not later than 2 years after the date 10

of enactment of the Frank R. Lautenberg Chemical Safety 11

for the 21st Century Act, the Administrator shall develop, 12

after providing public notice and an opportunity for com-13

ment, any policies, procedures, and guidance the Adminis-14

trator determines to be necessary to carry out sections 4, 15

4A, 5, and 6, including the policies, procedures, and guid-16

ance required by this section. 17

‘‘(c) USE OF SCIENCE.— 18


tablish policies, procedures, and guidance on the use 20

of science in making decisions under sections 4, 4A, 21

5, and 6. 22

‘‘(2) GOAL.—A goal of the policies, procedures, 23

and guidance described in paragraph (1) shall be to 24



alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

180

•S 697 RS

‘‘(3) REQUIREMENTS.—The policies, procedures, 1

and guidance issued under this section shall describe 2

the manner in which the Administrator shall ensure 3

that — 4

‘‘(A) decisions made by the Adminis-5

trator— 6

‘‘(i) are based on information, proce-7

dures, measures, methods, and models em-8

ployed in a manner consistent with the best 9

available science; 10

‘‘(ii) take into account the extent to 11

which— 12

‘‘(I) assumptions and methods are 13

clearly and completely described and 14

documented; 15

‘‘(II) variability and uncertainty 16

are evaluated and characterized; and 17

‘‘(III) the information has been 18

subject to independent verification and 19

peer review; and 20

‘‘(iii) are based on the weight of the 21

scientific evidence, by which the Adminis-22

trator considers all information in a sys-23

tematic and integrative framework to con-24

sider the relevance of different information; 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

181

•S 697 RS

‘‘(B) to the extent practicable and if appro-1

priate, the use of peer review, standardized test 2

design and methods, consistent data evaluation 3

procedures, and good laboratory practices will be 4

encouraged; 5

‘‘(C) a clear description of each individual 6

and entity that funded the generation or assess-7

ment of information, and the degree of control 8

those individuals and entities had over the gen-9

eration, assessment, and dissemination of infor-10

mation (including control over the design of the 11

work and the publication of information) is 12

made available; and 13

‘‘(D) if appropriate, the recommendations 14

in reports of the National Academy of Sciences 15

that provide advice regarding assessing the haz-16

ards, exposures, and risks of chemical substances 17

are considered. 18

‘‘(d) EXISTING EPA POLICIES, PROCEDURES, AND 19

GUIDANCE.—The policies, procedures, and guidance de-20

scribed in subsection (b) shall incorporate, as appropriate, 21

existing relevant hazard, exposure, and risk assessment 22

guidelines and methodologies, data evaluation and quality 23

criteria, testing methodologies, and other relevant guidelines 24

and policies of the Environmental Protection Agency. 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

182

•S 697 RS

‘‘(e) REVIEW.—Not later than 5 years after the date 1


for the 21st Century Act, and not less frequently than once 3

every 5 years thereafter, the Administrator shall— 4

‘‘(1) review the adequacy of any policies, proce-5

dures, and guidance developed under this section, in-6

cluding animal, nonanimal, and epidemiological test 7

methods and procedures for assessing and deter-8

mining risk under this Act; and 9

‘‘(2) after providing public notice and an oppor-10

tunity for comment, revise the policies, procedures, 11

and guidance if necessary to reflect new scientific de-12

velopments or understandings. 13

‘‘(f) SOURCES OF INFORMATION.—In carrying out sec-14

tions 4, 4A, 5, and 6, the Administrator shall take into con-15

sideration information relating to a chemical substance, in-16

cluding hazard and exposure information, under the condi-17

tions of use that is reasonably available to the Adminis-18

trator, including information that is— 19

‘‘(1) submitted to the Administrator pursuant to 20

any rule, consent agreement, order, or other require-21

ment of this Act, or on a voluntary basis, including 22

pursuant to any request made under this Act, by— 23

‘‘(A) manufacturers or processors of a sub-24

stance; 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

183

•S 697 RS

‘‘(B) the public; 1

‘‘(C) other Federal departments or agencies; 2

or 3

‘‘(D) the Governor of a State or a State 4

agency with responsibility for protecting health 5

or the environment; 6

‘‘(2) submitted to a governmental entity in any 7

jurisdiction pursuant to a governmental requirement 8

relating to the protection of health or the environ-9

ment; or 10

‘‘(3) identified through an active search by the 11

Administrator of information sources that are pub-12

licly available or otherwise accessible by the Adminis-13

trator. 14

‘‘(g) TESTING OF CHEMICAL SUBSTANCES AND MIX-15

TURES.— 16


tablish policies and procedures for the testing of chem-18

ical substances or mixtures under section 4. 19


dures established under paragraph (1) shall be to 21


‘‘(3) CONTENTS.—The policies and procedures es-23

tablished under paragraph (1) shall— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

184

•S 697 RS

‘‘(A) address how and when the exposure 1

level or exposure potential of a chemical sub-2

stance would factor into decisions to require new 3

testing, subject to the condition that the Admin-4

istrator shall not interpret the lack of exposure 5

information as a lack of exposure or exposure po-6

tential; 7

‘‘(B) describe the manner in which the Ad-8

ministrator will determine that additional infor-9

mation is necessary to carry out this Act, includ-10

ing information relating to potentially exposed 11

or susceptible populations; 12

‘‘(C) require the Administrator to consult 13

with the Director of the National Institute for 14

Occupational Safety and Health prior to pre-15

scribing epidemiologic studies of employees; and 16

‘‘(D) require that prior to making a request 17

or adopting a requirement for testing using 18

vertebrate animals, the Administrator shall take 19

into consideration, as appropriate and to the ex-20

tent practicable, reasonably available— 21

‘‘(i) toxicity information; 22

‘‘(ii) computational toxicology and 23

bioinformatics; 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

185

•S 697 RS

‘‘(iii) high-throughput screening meth-1

ods and the prediction models of those meth-2

ods; and 3

‘‘(iv) scientifically reliable and rel-4

evant alternatives to tests on animals that 5

would provide equivalent information. 6

‘‘(h) SAFETY ASSESSMENTS AND SAFETY DETERMINA-7

TIONS.— 8

‘‘(1) SCHEDULE.— 9


shall inform the public regarding the schedule for 11

the completion of each safety assessment and 12

safety determination as soon as practicable after 13

designation as a high-priority substance pursu-14

ant to section 4A. 15

‘‘(B) DIFFERING TIMES.—The Adminis-16

trator may allot different times for different 17

chemical substances in the schedules under this 18

paragraph, subject to the condition that all 19

schedules shall comply with the deadlines estab-20

lished under section 6. 21

‘‘(C) ANNUAL PLAN.—At the beginning of 22

each calendar year, the Administrator shall iden-23

tify the substances subject to safety assessments 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

186

•S 697 RS

and safety determinations to be completed that 1

year. 2

‘‘(2) POLICIES AND PROCEDURES FOR SAFETY 3

ASSESSMENTS AND SAFETY DETERMINATIONS.— 4


shall establish, by rule, policies and procedures 6

regarding the manner in which the Adminis-7

trator shall carry out section 6. 8

‘‘(B) GOAL.—A goal of the policies and pro-9

cedures under this paragraph shall be to make 10

the basis of decisions of the Administrator clear 11

to the public. 12

‘‘(C) MINIMUM REQUIREMENTS.—At a min-13

imum, the policies and procedures under this 14

paragraph shall— 15

‘‘(i) describe— 16

‘‘(I) the manner in which the Ad-17

ministrator will identify informational 18

needs and seek that information from 19

the public; 20

‘‘(II) the information (including 21

draft safety assessments) that may be 22

submitted by interested individuals or 23

entities, including States; and 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

187

•S 697 RS

‘‘(III) the criteria by which that 1

information will be evaluated; 2

‘‘(ii) require the Administrator— 3

‘‘(I)(aa) to define the scope of the 4

safety assessment and safety deter-5

mination to be conducted under section 6

6, including the hazards, exposures, 7

conditions of use, and potentially ex-8

posed and susceptible populations that 9

the Administrator expects to consider 10

in a safety assessment; 11


scope of the safety assessment and safe-13

ty determination; and 14

‘‘(cc) to accept comments regard-15

ing the scope of the safety assessment 16


‘‘(II)(aa) to identify the items de-18

scribed in subclause (I) that the Ad-19

ministrator has considered in the final 20

safety assessment; and 21


consideration of those items; 23

‘‘(iii) describe the manner in which ag-24

gregate exposures, or significant subsets of 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

188

•S 697 RS

exposures, to a chemical substance under the 1

conditions of use will be considered, and ex-2

plain the basis for that consideration in the 3

final safety assessment; 4

‘‘(iv) require that each safety assess-5

ment and safety determination shall in-6

clude— 7

‘‘(I) a description of the weight of 8

the scientific evidence of risk; and 9

‘‘(II) a summary of the informa-10

tion regarding the impact on health 11

and the environment of the chemical 12

substance that was used to make the 13

assessment or determination, includ-14

ing, as available, mechanistic, animal 15

toxicity, and epidemiology studies; 16

‘‘(v) establish a timely and transparent 17

process for evaluating whether new informa-18

tion submitted or obtained after the date of 19

a final safety assessment or safety deter-20

mination warrants reconsideration of the 21

safety assessment or safety determination; 22

and 23

‘‘(vi) when relevant information is pro-24

vided or otherwise made available to the 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

189

•S 697 RS

Administrator, shall consider the extent of 1

Federal regulation under other Federal 2

laws. 3

‘‘(D) GUIDANCE.— 4





shall develop guidance to assist interested 9

persons in developing their own draft safety 10

assessments and other information for sub-11

mission to the Administrator, which may be 12

considered at the discretion of the Adminis-13

trator. 14

‘‘(ii) REQUIREMENT.—The guidance 15

shall, at a minimum, address the quality of 16

the information submitted and the process 17

to be followed in developing a draft safety 18

assessment for consideration by the Admin-19

istrator. 20

‘‘(i) PUBLICLY AVAILABLE INFORMATION.—Subject to 21

section 14, the Administrator shall— 22

‘‘(1) make publicly available a nontechnical 23

summary, and the final version, of each safety assess-24

ment and safety determination; 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

190

•S 697 RS

‘‘(2) provide public notice and an opportunity 1

for comment on each proposed safety assessment and 2

safety determination; and 3

‘‘(3) make public in a final safety assessment 4


‘‘(A) the list of studies considered by the Ad-6

ministrator in carrying out the safety assessment 7

or safety determination; and 8

‘‘(B) the list of policies, procedures, and 9

guidance that were followed in carrying out the 10

safety assessment or safety determination. 11

‘‘(j) CONSULTATION WITH SCIENCE ADVISORY COM-12

MITTEE ON CHEMICALS.— 13

‘‘(1) ESTABLISHMENT.—Not later than 1 year 14

after the date of enactment of this section, the Admin-15

istrator shall establish an advisory committee, to be 16

known as the ‘Science Advisory Committee on Chemi-17

cals’ (referred to in this subsection as the ‘Com-18

mittee’). 19

‘‘(2) PURPOSE.—The purpose of the Committee 20

shall be to provide independent advice and expert 21

consultation, on the request of the Administrator, 22

with respect to the scientific and technical aspects of 23

issues relating to the implementation of this title. 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

191

•S 697 RS

‘‘(3) COMPOSITION.—The Committee shall be 1

composed of representatives of such science, govern-2

ment, labor, public health, public interest, animal 3

protection, industry, and other groups as the Admin-4

istrator determines to be advisable, including, at a 5

minimum, representatives that have specific scientific 6

expertise in the relationship of chemical exposures to 7

women, children, and other potentially exposed or 8

susceptible populations. 9

‘‘(4) SCHEDULE.—The Administrator shall con-10

vene the Committee in accordance with such schedule 11

as the Administrator determines to be appropriate, 12

but not less frequently than once every 2 years. 13

‘‘(5) RELATIONSHIP TO OTHER LAW.—All pro-14

ceedings and meetings of the Committee shall be sub-15

ject to the Federal Advisory Committee Act (5 U.S.C. 16

App.).’’. 17

SEC. 5. TESTING OF CHEMICAL SUBSTANCES OR MIXTURES. 18

(a) IN GENERAL.—Section 4 of the Toxic Substances 19

Control Act (15 U.S.C. 2603) is amended— 20

(1) by striking subsections (a), (b), (c), (d), and 21

(g); 22


subsections (f) and (g), respectively; 24

(3) in subsection (f) (as so redesignated)— 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

192

•S 697 RS

(A) by striking ‘‘rule’’ each place it appears 1

and inserting ‘‘rule, testing consent agreement, 2

or order’’; 3

(B) by striking ‘‘under subsection (a)’’ each 4

place it appears and inserting ‘‘under this sub-5

section’’; and 6

(C) in paragraph (1)— 7

(i) in subparagraph (A)(v), by insert-8

ing ‘‘, without taking into account cost or 9

other nonrisk factors’’ after ‘‘the environ-10

ment’’; and 11

(ii) in subparagraph (B), in the last 12

sentence, by striking ‘‘rulemaking’’; 13

(4) in subsection (g) (as so redesignated)— 14


(i) by striking ‘‘from cancer, gene 16

mutations, or birth defects’’; and 17

(ii) by inserting ‘‘, without taking into 18

account cost or other nonrisk factors’’ before 19

the period at the end; and 20

(B) by striking the last sentence; and 21

(5) by inserting before subsection (f) (as so redes-22

ignated) the following: 23

‘‘(a) DEVELOPMENT OF NEW INFORMATION ON CHEM-24

ICAL SUBSTANCES AND MIXTURES.— 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

193

•S 697 RS


quire the development of new information relating to 2

a chemical substance or mixture in accordance with 3

this section if the Administrator determines that the 4

information is necessary— 5

‘‘(A) to review a notice under section 5(d) 6

or to perform a safety assessment or safety deter-7

mination under section 6; 8

‘‘(B) to implement a requirement imposed 9

in a consent agreement or order issued under 10

section 5(d)(4) or under a rule promulgated 11

under section 6(d)(3); 12

‘‘(C) pursuant to section 12(a)(4); or 13

‘‘(D) at the request of the implementing au-14

thority under another Federal law, to meet the 15

regulatory testing needs of that authority. 16

‘‘(2) LIMITED TESTING FOR PRIORITIZATION 17

PURPOSES.— 18


subparagraph (B), the Administrator may re-20

quire the development of new information for the 21

purposes of section 4A. 22

‘‘(B) PROHIBITION.—Testing required 23

under subparagraph (A) shall not be required for 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

194

•S 697 RS

the purpose of establishing or implementing a 1

minimum information requirement. 2

‘‘(C) LIMITATION.—The Administrator may 3

require the development of new information pur-4

suant to subparagraph (A) only if the Adminis-5

trator determines that additional information is 6

necessary to establish the priority of a chemical 7

substance. 8

‘‘(3) FORM.—The Administrator may require the 9

development of information described in paragraph 10

(1) or (2) by— 11

‘‘(A) promulgating a rule; 12

‘‘(B) entering into a testing consent agree-13

ment; or 14

‘‘(C) issuing an order. 15

‘‘(4) CONTENTS.— 16

‘‘(A) IN GENERAL.—A rule, testing consent 17

agreement, or order issued under this subsection 18

shall include— 19

‘‘(i) identification of the chemical sub-20

stance or mixture for which testing is re-21

quired; 22

‘‘(ii) identification of the persons re-23

quired to conduct the testing; 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

195

•S 697 RS

‘‘(iii) test protocols and methodologies 1

for the development of information for the 2

chemical substance or mixture, including 3

specific reference to any reliable nonanimal 4

test procedures; and 5

‘‘(iv) specification of the period within 6

which individuals and entities required to 7

conduct the testing shall submit to the Ad-8

ministrator the information developed in 9

accordance with the procedures described in 10

clause (iii). 11

‘‘(B) CONSIDERATIONS.—In determining 12

the procedures and period to be required under 13

subparagraph (A), the Administrator shall take 14

into consideration— 15

‘‘(i) the relative costs of the various test 16

protocols and methodologies that may be re-17

quired; and 18

‘‘(ii) the reasonably foreseeable avail-19

ability of facilities and personnel required 20

to perform the testing. 21

‘‘(b) STATEMENT OF NEED.— 22

‘‘(1) IN GENERAL.—In promulgating a rule, en-23

tering into a testing consent agreement, or issuing an 24

order for the development of additional information 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

196

•S 697 RS

(including information on exposure or exposure po-1

tential) pursuant to this section, the Administrator 2

shall— 3

‘‘(A) identify the need intended to be met by 4

the rule, agreement, or order; 5

‘‘(B) explain why information reasonably 6

available to the Administrator at that time is in-7

adequate to meet that need, including a ref-8

erence, as appropriate, to the information identi-9

fied in paragraph (2)(B); and 10

‘‘(C) explain the basis for any decision that 11

requires the use of vertebrate animals. 12

‘‘(2) EXPLANATION IN CASE OF ORDER.— 13


issues an order under this section, the Adminis-15

trator shall issue a statement providing a jus-16

tification for why issuance of an order is war-17

ranted instead of promulgating a rule or enter-18

ing into a testing consent agreement. 19

‘‘(B) CONTENTS.—A statement described in 20

subparagraph (A) shall contain a description 21

of— 22

‘‘(i) information that is readily acces-23

sible to the Administrator, including infor-24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

197

•S 697 RS

mation submitted under any other provi-1

sion of law; 2

‘‘(ii) the extent to which the Adminis-3

trator has obtained or attempted to obtain 4

the information through voluntary submis-5

sions; and 6

‘‘(iii) any information relied on in 7

safety assessments for other chemical sub-8

stances relevant to the chemical substances 9

that would be the subject of the order. 10

‘‘(c) REDUCTION OF TESTING ON VERTEBRATES.— 11

‘‘(1) IN GENERAL.—The Administrator shall 12

minimize, to the extent practicable, the use of 13

vertebrate animals in testing of chemical substances 14

or mixtures, by— 15

‘‘(A) encouraging and facilitating— 16

‘‘(i) the use of integrated and tiered 17

testing and assessment strategies; 18

‘‘(ii) the use of best available science in 19

existence on the date on which the test is 20

conducted; 21

‘‘(iii) the use of test methods that 22

eliminate or reduce the use of animals while 23

providing information of high scientific 24

quality; 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

198

•S 697 RS

‘‘(iv) the grouping of 2 or more chem-1

ical substances into scientifically appro-2

priate categories in cases in which testing of 3

a chemical substance would provide reliable 4

and useful information on other chemical 5

substances in the category; 6

‘‘(v) the formation of industry con-7

sortia to jointly conduct testing to avoid 8

unnecessary duplication of tests; and 9

‘‘(vi) the submission of information 10

from— 11

‘‘(I) animal-based studies; and 12

‘‘(II) emerging methods and mod-13

els; and 14

‘‘(B) funding research and validation stud-15

ies to reduce, refine, and replace the use of ani-16

mal tests in accordance with this subsection. 17

‘‘(2) IMPLEMENTATION OF ALTERNATIVE TESTING 18

METHODS.—To promote the development and timely 19

incorporation of new testing methods that are not 20

based on vertebrate animals, the Administrator 21

shall— 22

‘‘(A) not later than 2 years after the date 23

of enactment of the Frank R. Lautenberg Chem-24

ical Safety for the 21st Century Act, develop a 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

199

•S 697 RS

strategic plan to promote the development and 1

implementation of alternative test methods and 2

testing strategies to generate information under 3

this title that can reduce, refine, or replace the 4

use of vertebrate animals, including toxicity 5

pathway-based risk assessment, in vitro studies, 6

systems biology, computational toxicology, 7

bioinformatics, and high-throughput screening; 8

‘‘(B) as practicable, ensure that the stra-9

tegic plan developed under subparagraph (A) is 10

reflected in the development of requirements for 11

testing under this section; 12

‘‘(C) identify in the strategic plan developed 13

under subparagraph (A) particular alternative 14

test methods or testing strategies that do not re-15

quire new vertebrate animal testing and are sci-16

entifically reliable, relevant, and capable of pro-17

viding information of equivalent scientific reli-18

ability and quality to that which would be ob-19

tained from vertebrate animal testing; 20

‘‘(D) provide an opportunity for public no-21

tice and comment on the contents of the plan de-22

veloped under subparagraph (A), including the 23

criteria for considering scientific reliability, rel-24

evance, and equivalent information and the test 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

200

•S 697 RS

methods and strategies identified in subpara-1

graph (C); 2

‘‘(E) beginning on the date that is 5 years 3

after the date of enactment of the Frank R. Lau-4

tenberg Chemical Safety for the 21st Century Act 5

and every 5 years thereafter, submit to Congress 6

a report that describes the progress made in im-7

plementing this subsection and goals for future 8

alternative test methods implementation; 9

‘‘(F) fund and carry out research, develop-10

ment, performance assessment, and translational 11

studies to accelerate the development of test meth-12

ods and testing strategies that reduce, refine, or 13

replace the use of vertebrate animals in any test-14

ing under this title; and 15

‘‘(G) identify synergies with the related in-16

formation requirements of other jurisdictions to 17

minimize the potential for additional or duplica-18

tive testing. 19

‘‘(3) CRITERIA FOR ADAPTING OR WAIVING ANI-20

MAL TESTING REQUIREMENTS.—On request from a 21

manufacturer or processor that is required to conduct 22

testing of a chemical substance or mixture on 23

vertebrate animals under this section, the Adminis-24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

201

•S 697 RS

trator may adapt or waive the requirement, if the Ad-1

ministrator determines that— 2

‘‘(A) there is sufficient evidence from several 3

independent sources of information to support a 4

conclusion that a chemical substance or mixture 5

has, or does not have, a particular property if 6

the information from each individual source 7

alone is insufficient to support the conclusion; 8

‘‘(B) as a result of 1 or more physical or 9

chemical properties of the chemical substance or 10

mixture or other toxicokinetic considerations— 11

‘‘(i) the substance cannot be absorbed; 12

or 13

‘‘(ii) testing for a specific endpoint is 14

technically not practicable to conduct; or 15

‘‘(C) a chemical substance or mixture can-16

not be tested in vertebrate animals at concentra-17

tions that do not result in significant pain or 18

distress, because of physical or chemical prop-19

erties of the chemical substance or mixture, such 20

as a potential to cause severe corrosion or severe 21

irritation to the tissues of the animal. 22

‘‘(4) VOLUNTARY TESTING.— 23

‘‘(A) IN GENERAL.—Any person developing 24

information for submission under this title on a 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

202

•S 697 RS

voluntary basis and not pursuant to any request 1

or requirement by the Administrator shall first 2

attempt to develop the information by means of 3

an alternative or nonanimal test method or test-4

ing strategy that the Administrator has deter-5

mined under paragraph (2)(C) to be scientif-6

ically reliable, relevant, and capable of providing 7

equivalent information, before conducting new 8

animal testing. 9

‘‘(B) EFFECT OF PARAGRAPH.—Nothing in 10

this paragraph— 11

‘‘(i) requires the Administrator to re-12

view the basis on which the person is con-13

ducting testing described in subparagraph 14

(A); 15

‘‘(ii) prohibits the use of other test 16

methods or testing strategies by any person 17

for purposes other than developing informa-18

tion for submission under this title on a 19

voluntary basis; or 20

‘‘(iii) prohibits the use of other test 21

methods or testing strategies by any person, 22

subsequent to the attempt to develop infor-23

mation using the test methods and testing 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

203

•S 697 RS

strategies identified by the Administrator 1

under paragraph (2)(C). 2

‘‘(d) TESTING REQUIREMENTS.— 3


quire the development of information by— 5

‘‘(A) manufacturers and processors of the 6

chemical substance or mixture; and 7

‘‘(B) subject to paragraph (3), persons that 8

begin to manufacture or process the chemical 9

substance or mixture— 10

‘‘(i) after the effective date of the rule, 11

testing consent agreement, or order; but 12

‘‘(ii) before the period ending on the 13

later of— 14

‘‘(I) 5 years after the date referred 15

to in clause (i); or 16

‘‘(II) the last day of the period 17

that begins on the date referred to in 18

clause (i) and that is equal to the pe-19

riod that the Administrator determines 20

was necessary to develop the informa-21

tion. 22

‘‘(2) DESIGNATION.—The Administrator may 23

permit 2 or more persons identified in subparagraph 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

204

•S 697 RS

(A) or (B) of paragraph (1) to designate 1 of the per-1

sons or a qualified third party— 2

‘‘(A) to develop the information; and 3

‘‘(B) to submit the information on behalf of 4

the persons making the designation. 5


‘‘(A) IN GENERAL.—A person otherwise sub-7

ject to a rule, testing consent agreement, or order 8

under this section may submit to the Adminis-9

trator an application for an exemption on the 10

basis that the information is being developed by 11

a person designated under paragraph (2). 12

‘‘(B) FAIR AND EQUITABLE REIMBURSE-13

MENT TO DESIGNEE.— 14


trator accepts an application submitted 16


shall direct the applicant to provide to the 18

person designated under paragraph (2) fair 19

and equitable reimbursement, as agreed to 20

between the applicant and the designee. 21

‘‘(ii) ARBITRATION.—If the applicant 22

and a person designated under paragraph 23

(2) cannot reach agreement on the amount 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

205

•S 697 RS

of fair and equitable reimbursement, the 1

amount shall be determined by arbitration. 2

‘‘(C) TERMINATION.—If, after granting an 3

exemption under this paragraph, the Adminis-4

trator determines that no person designated 5

under paragraph (2) has complied with the rule, 6

testing consent agreement, or order, the Adminis-7

trator shall— 8

‘‘(i) by order, terminate the exemption; 9

and 10

‘‘(ii) notify in writing each person that 11

received an exemption of the requirements 12

with respect to which the exemption was 13

granted. 14

‘‘(4) TIERED TESTING.— 15


subparagraph (D), the Administrator shall em-17

ploy a tiered screening and testing process, 18

under which the results of screening-level tests or 19

assessments of available information inform the 20

decision as to whether 1 or more additional tests 21

are necessary. 22

‘‘(B) SCREENING-LEVEL TESTS.— 23

‘‘(i) IN GENERAL.—The screening-level 24

tests required for a chemical substance or 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

206

•S 697 RS

mixture may include tests for hazard 1

(which may include in silico, in vitro, and 2

in vivo tests), environmental and biological 3

fate and transport, and measurements or 4

modeling of exposure or exposure potential, 5

as appropriate. 6

‘‘(ii) USE.—Screening-level tests shall 7

be used— 8

‘‘(I) to screen chemical substances 9

or mixtures for potential adverse ef-10

fects; and 11

‘‘(II) to inform a decision of the 12

Administrator regarding whether more 13

complex or targeted additional testing 14

is necessary. 15

‘‘(C) ADDITIONAL TESTING.—If the Admin-16

istrator determines under subparagraph (B) that 17

additional testing is necessary to provide more 18

definitive information for safety assessments or 19

safety determinations, the Administrator may 20

require more advanced tests for potential health 21

or environmental effects or exposure potential. 22

‘‘(D) ADVANCED TESTING WITHOUT 23

SCREENING.—The Administrator may require 24

more advanced testing without conducting 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

207

•S 697 RS

screening-level testing when other information 1

available to the Administrator justifies the ad-2

vanced testing, pursuant to guidance developed 3

by the Administrator under this section. 4

‘‘(e) TRANSPARENCY.—Subject to section 14, the Ad-5

ministrator shall make available to the public all testing 6

consent agreements and orders and all information sub-7

mitted under this section.’’. 8

(b) CONFORMING AMENDMENT.—Section 104(i)(5)(A) 9

of the Comprehensive Environmental Response, Compensa-10

tion, and Liability Act of 1980 (42 U.S.C. 9604(i)(5)(A)) 11

is amended in the third sentence by striking ‘‘section 4(e)’’ 12

and inserting ‘‘section 4(f)’’. 13

SEC. 6. PRIORITIZATION SCREENING. 14



‘‘SEC. 4A. PRIORITIZATION SCREENING. 17

‘‘(a) PRIORITIZATION SCREENING PROCESS AND LIST 18

OF SUBSTANCES.— 19

‘‘(1) IN GENERAL.—Not later than 1 year after 20

the date of enactment of this section, the Adminis-21

trator shall establish, by rule, a risk-based screening 22

process and explicit criteria for identifying existing 23

chemical substances that are— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

208

•S 697 RS

‘‘(A) a high priority for a safety assessment 1

and safety determination under section 6 (re-2

ferred to in this Act as ‘high-priority sub-3

stances’); and 4

‘‘(B) a low priority for a safety assessment 5

and safety determination (referred to in this Act 6

as ‘low-priority substances’). 7

‘‘(2) INITIAL LIST OF HIGH- AND LOW-PRIORITY 8

SUBSTANCES.— 9

‘‘(A) IN GENERAL.—Before the date of pro-10

mulgation of the rule under paragraph (1) and 11

not later than 180 days after the date of enact-12

ment of this section, the Administrator— 13

‘‘(i) shall take into consideration and 14

publish an initial list of high-priority sub-15

stances and low-priority substances; and 16

‘‘(ii) pursuant to section 6(b), may 17

initiate or continue safety assessments and 18

safety determinations for those high-priority 19

substances. 20

‘‘(B) REQUIREMENTS.— 21

‘‘(i) IN GENERAL.—The initial list of 22

chemical substances shall contain at least 23

10 high-priority substances, at least 5 of 24

which are drawn from the list of chemical 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

209

•S 697 RS

substances identified by the Administrator 1

in the October 2014 TSCA Work Plan and 2

subsequent updates, and at least 10 low-pri-3

ority substances. 4

‘‘(ii) SUBSEQUENTLY IDENTIFIED SUB-5

STANCES.—Insofar as possible, at least 50 6

percent of all substances subsequently iden-7

tified by the Administrator as high-priority 8

substances shall be drawn from the list of 9

chemical substances identified by the Ad-10

ministrator in the October 2014 TSCA 11

Work Plan and subsequent updates, until 12

all Work Plan chemicals have been des-13

ignated under this subsection. 14

‘‘(iii) PERSISTENCE AND BIOACCUMU-15

LATION.—In developing the initial list and 16

in identifying additional high-priority sub-17

stances, the Administrator shall give pref-18

erence to chemical substances scored as high 19

for persistence and bioaccumulation in the 20

October 2014 TSCA Work Plan and subse-21

quent updates. 22

‘‘(C) ADDITIONAL CHEMICAL REVIEWS.— 23

The Administrator shall, as soon as practicable 24

and not later than— 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

210

•S 697 RS

‘‘(i) 3 years after the date of enactment 1

of the Frank R. Lautenberg Chemical Safe-2

ty for the 21st Century Act, add additional 3

high-priority substances sufficient to ensure 4

that at least a total of 20 high-priority sub-5

stances have undergone or are undergoing 6

the process established in section 6(a), and 7

additional low-priority substances sufficient 8

to ensure that at least a total of 20 low-pri-9

ority substances have been designated; and 10

‘‘(ii) 5 years after the date of enact-11

ment of the Frank R. Lautenberg Chemical 12

Safety for the 21st Century Act, add addi-13

tional high-priority substances sufficient to 14

ensure that at least a total of 25 high-pri-15

ority substances have undergone or are un-16

dergoing the process established in section 17

6(a), and additional low-priority substances 18

sufficient to ensure that at least a total of 19

25 low-priority substances have been des-20

ignated. 21

‘‘(3) IMPLEMENTATION.— 22

‘‘(A) CONSIDERATION OF ACTIVE AND INAC-23

TIVE SUBSTANCES.— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

211

•S 697 RS

‘‘(i) ACTIVE SUBSTANCES.—In car-1


shall take into consideration active sub-3


which may include chemical substances on 5

the interim list of active substances estab-6

lished under that section. 7

‘‘(ii) INACTIVE SUBSTANCES.—In car-8


may take into consideration inactive sub-10

stances, as determined under section 8, that 11

the Administrator determines— 12

‘‘(I)(aa) have not been subject to a 13




‘‘(bb) have the potential for high 17

hazard and widespread exposure; or 18

‘‘(II)(aa) have been subject to a 19




‘‘(bb) with respect to which there 23

exists the potential for residual high 24

hazards or widespread exposures not 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

212

•S 697 RS

otherwise addressed by the regulatory 1

or other action. 2

‘‘(iii) REPOPULATION.— 3

‘‘(I) IN GENERAL.—On the com-4

pletion of a safety determination under 5

section 6 for a chemical substance, the 6

Administrator shall remove the chem-7

ical substance from the list of high-pri-8

ority substances established under this 9

subsection. 10

‘‘(II) ADDITIONS.—The Adminis-11

trator shall add at least 1 chemical 12

substance to the list of high-priority 13

substances for each chemical substance 14

removed from the list of high-priority 15

substances established under this sub-16

section, until a safety assessment and 17

safety determination is completed for 18

all high-priority substances. 19

‘‘(III) LOW-PRIORITY SUB-20

STANCES.—If a low-priority substance 21

is subsequently designated as a high- 22

priority substance, the Administrator 23

shall remove that substance from the 24

list of low-priority substances. 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

213

•S 697 RS

‘‘(B) TIMELY COMPLETION OF 1

PRIORITIZATION SCREENING PROCESS.— 2


shall— 4

‘‘(I) except as provided under 5

paragraph (2), not later than 180 days 6

after the effective date of the final rule 7

under paragraph (1), begin the 8

prioritization screening process; and 9

‘‘(II) make every effort to complete 10

the designation of all active substances 11

as high-priority substances or low-pri-12

ority substances in a timely manner. 13

‘‘(ii) DECISIONS ON SUBSTANCES SUB-14

JECT TO TESTING FOR PRIORITIZATION 15

PURPOSES.—Not later than 90 days after 16

the date of receipt of information regarding 17

a chemical substance complying with a rule, 18

testing consent agreement, or order issued 19

under section 4(a)(2), the Administrator 20

shall designate the chemical substance as a 21

high-priority substance or low-priority sub-22

stance. 23

‘‘(iii) CONSIDERATION.— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

214

•S 697 RS

‘‘(I) IN GENERAL.—The Adminis-1

trator shall screen substances and des-2

ignate high-priority substances taking 3

into consideration the ability of the 4

Administrator to schedule and com-5

plete safety assessments and safety de-6

terminations under section 6 in a 7

timely manner. 8



goal for the number of chemical sub-11

stances to be subject to the 12

prioritization screening process. 13

‘‘(C) SCREENING OF CATEGORIES OF SUB-14

STANCES.—The Administrator may screen cat-15

egories of chemical substances to ensure an effi-16

cient prioritization screening process to allow for 17

timely and adequate designations of high-pri-18

ority substances and low-priority substances and 19

safety assessments and safety determinations for 20

high-priority substances. 21

‘‘(D) PUBLICATION OF LIST OF CHEMICAL 22

SUBSTANCES.—The Administrator shall keep 23

current and publish a list of chemical substances 24

that— 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

215

•S 697 RS

‘‘(i) are being considered in the 1

prioritization screening process and the sta-2

tus of the chemical substances in the 3

prioritization process, including those chem-4

ical substances for which prioritization de-5

cisions have been deferred; and 6

‘‘(ii) are designated as high-priority 7

substances or low-priority substances, in-8

cluding the bases for such designations. 9

‘‘(4) CRITERIA.—The criteria described in para-10

graph (1) shall account for— 11

‘‘(A) the recommendation of the Governor of 12

a State or a State agency with responsibility for 13

protecting health or the environment from chem-14

ical substances appropriate for prioritization 15

screening; 16

‘‘(B) the hazard and exposure potential of 17

the chemical substance (or category of sub-18

stances), including persistence, bioaccumulation, 19

and specific scientific classifications and des-20

ignations by authoritative governmental entities; 21

‘‘(C) the conditions of use or significant 22

changes in the conditions of use of the chemical 23

substance; 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

216

•S 697 RS

‘‘(D) evidence and indicators of exposure 1

potential to humans or the environment from the 2

chemical substance, including potentially exposed 3

or susceptible populations; 4

‘‘(E) the volume of a chemical substance 5

manufactured or processed; 6

‘‘(F) whether the volume of a chemical sub-7

stance as reported under a rule promulgated 8

pursuant to section 8(a) has significantly in-9

creased or decreased during the period beginning 10

on the date of a previous report or the date on 11

which a notice has been submitted under section 12

5(b) for that chemical substance; 13

‘‘(G) the availability of information regard-14

ing potential hazards and exposures required for 15

conducting a safety assessment or safety deter-16

mination, with limited availability of relevant 17

information to be a sufficient basis for desig-18

nating a chemical substance as a high-priority 19

substance, subject to the condition that limited 20

availability shall not require designation as a 21

high-priority substance; and 22

‘‘(H) the extent of Federal or State regula-23

tion of the chemical substance or the extent of the 24

impact of State regulation of the chemical sub-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

217

•S 697 RS

stance on the United States, with existing Fed-1

eral or State regulation of any uses evaluated in 2

the prioritization screening process as a factor in 3

designating a chemical substance to be a high- 4

priority or a low-priority substance. 5

‘‘(b) PRIORITIZATION SCREENING PROCESS AND DECI-6

SIONS.— 7


process developed under subsection (a) shall include a 9

requirement that the Administrator shall— 10

‘‘(A) identify the chemical substances being 11

considered for prioritization; 12

‘‘(B) request interested persons to supply 13

information regarding the chemical substances 14

being considered; 15

‘‘(C) apply the criteria identified in sub-16

section (a)(4); and 17

‘‘(D) subject to paragraph (5) and using the 18

information available to the Administrator at 19

the time of the decision, identify a chemical sub-20

stance as a high-priority substance or a low-pri-21

ority substance. 22

‘‘(2) INTEGRATION OF INFORMATION.—The 23

prioritization screening decision regarding a chemical 24

substance shall integrate any hazard and exposure in-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

218

•S 697 RS

formation relating to the chemical substance that is 1

available to the Administrator. 2

‘‘(3) IDENTIFICATION OF HIGH-PRIORITY SUB-3

STANCES.—The Administrator— 4

‘‘(A) shall identify as a high-priority sub-5


other active chemical substances, the Adminis-7

trator determines has the potential for signifi-8

cant hazard and significant exposure; 9

‘‘(B) may identify as a high-priority sub-10


other active chemical substances, the Adminis-12

trator determines has the potential for signifi-13

cant hazard or significant exposure; and 14

‘‘(C) may identify as a high-priority sub-15

stance an inactive substance, as determined 16

under subsection (a)(3)(A)(ii) and section 8(b), 17

that the Administrator determines warrants a 18

safety assessment and safety determination 19

under section 6. 20

‘‘(4) IDENTIFICATION OF LOW-PRIORITY SUB-21

STANCES.—The Administrator shall identify as a low- 22

priority substance a chemical substance that the Ad-23

ministrator concludes has information sufficient to es-24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

219

•S 697 RS

tablish that the chemical substance is likely to meet 1

the safety standard. 2

‘‘(5) DEFERRING A DECISION.—If the Adminis-3

trator determines that additional information is re-4

quired to establish the priority of a chemical sub-5

stance under this section, the Administrator may 6

defer the prioritization screening decision for a rea-7

sonable period— 8

‘‘(A) to allow for the submission of addi-9

tional information by an interested person and 10

for the Administrator to evaluate the additional 11

information; or 12

‘‘(B) to require the development of informa-13

tion pursuant to a rule, testing consent agree-14

ment, or order issued under section 4(a)(2). 15

‘‘(6) DEADLINES FOR SUBMISSION OF INFORMA-16

TION.—If the Administrator requests the development 17

or submission of information under this section, the 18

Administrator shall establish a deadline for submis-19

sion of the information. 20

‘‘(7) NOTICE AND COMMENT.—The Administrator 21

shall— 22

‘‘(A) publish, including in the Federal Reg-23

ister, the proposed decisions made under para-24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

220

•S 697 RS

graphs (3), (4), and (5) and the basis for the de-1

cisions; and 2

‘‘(B) provide 90 days for public comment. 3

‘‘(8) REVISIONS OF PRIOR DESIGNATIONS.— 4

‘‘(A) IN GENERAL.—At any time, and at the 5

discretion of the Administrator, the Adminis-6

trator may revise the designation of a chemical 7

substance as a high-priority substance or a low- 8

priority substance based on information avail-9

able to the Administrator after the date of the de-10

termination under paragraph (3) or (4). 11

‘‘(B) LIMITED AVAILABILITY.—If limited 12

availability of relevant information was a basis 13

in the designation of a chemical substance as a 14

high-priority substance, the Administrator shall 15

reevaluate the prioritization screening of the 16

chemical substance on receiving the relevant in-17

formation. 18

‘‘(9) OTHER INFORMATION RELEVANT TO 19

PRIORITIZATION.— 20

‘‘(A) IN GENERAL.—If, after the date of en-21

actment of the Frank R. Lautenberg Chemical 22

Safety for the 21st Century Act, a State proposes 23

an administrative action or enacts a statute or 24

takes an administrative action to prohibit or 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

221

•S 697 RS

otherwise restrict the manufacturing, processing, 1

distribution in commerce, or use of a chemical 2

substance that the Administrator has not des-3

ignated as a high-priority substance, the Gov-4

ernor or State agency with responsibility for im-5

plementing the statute or administrative action 6

shall notify the Administrator. 7

‘‘(B) REQUESTS FOR INFORMATION.—Fol-8

lowing receipt of a notification provided under 9

subparagraph (A), the Administrator may re-10

quest any available information from the Gov-11

ernor or the State agency with respect to— 12

‘‘(i) scientific evidence related to the 13

hazards, exposures and risks of the chemical 14

substance under the conditions of use which 15

the statute or administrative action is in-16

tended to address; 17

‘‘(ii) any State or local conditions 18

which warranted the statute or administra-19

tive action; 20

‘‘(iii) the statutory or administrative 21

authority on which the action is based; and 22

‘‘(iv) any other available information 23

relevant to the prohibition or other restric-24

tion, including information on any alter-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

222

•S 697 RS

natives considered and their hazards, expo-1

sures, and risks. 2

‘‘(C) PRIORITIZATION SCREENING.—The 3

Administrator shall conduct a prioritization 4

screening under this subsection for all substances 5

that— 6

‘‘(i) are the subject of notifications re-7

ceived under subparagraph (A); and 8

‘‘(ii) the Administrator determines— 9

‘‘(I) are likely to have significant 10

health or environmental impacts; 11

‘‘(II) are likely to have significant 12

impact on interstate commerce; or 13

‘‘(III) have been subject to a pro-14

hibition or other restriction under a 15

statute or administrative action in 2 16

or more States. 17

‘‘(D) AVAILABILITY TO PUBLIC.—Subject to 18

section 14 and any applicable State law regard-19

ing the protection of confidential information 20

provided to the State or to the Administrator, 21

the Administrator shall make information re-22

ceived from a Governor or State agency under 23

subparagraph (A) publicly available. 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

223

•S 697 RS

‘‘(E) EFFECT OF PARAGRAPH.—Nothing in 1

this paragraph shall preempt a State statute or 2

administrative action, require approval of a 3

State statute or administrative action, or apply 4

section 15 to a State. 5

‘‘(10) REVIEW.—Not less frequently than once 6

every 5 years after the date on which the process 7

under this subsection is established, the Administrator 8

shall— 9

‘‘(A) review the process on the basis of expe-10

rience and taking into consideration resources 11

available to efficiently and effectively screen and 12

prioritize chemical substances; and 13

‘‘(B) if necessary, modify the prioritization 14

screening process. 15

‘‘(11) EFFECT.—Subject to section 18, a designa-16

tion by the Administrator under this section with re-17

spect to a chemical substance shall not affect— 18



ical substance; or 21

‘‘(B) the regulation of those activities. 22

‘‘(c) ADDITIONAL PRIORITIES FOR SAFETY ASSESS-23

MENTS AND DETERMINATIONS.— 24



alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

224

•S 697 RS

‘‘(A) IN GENERAL.—The prioritization 1

screening process developed under subsection (a) 2

shall— 3

‘‘(i) include a process by which a man-4

ufacturer or processor of an active chemical 5

substance that has not been designated a 6

high-priority substance or is not in the 7

process of a prioritization screening by the 8

Administrator, may request that the Ad-9

ministrator designate the substance as an 10

additional priority for a safety assessment 11

and safety determination, subject to the 12

payment of fees pursuant to section 13

26(b)(3)(E); 14

‘‘(ii) specify the information to be pro-15

vided in such requests; and 16

‘‘(iii) specify the criteria the Adminis-17

trator shall use to determine whether or not 18

to grant such a request, which shall include 19

whether the substance is subject to restric-20

tions imposed by statutes enacted or admin-21

istrative actions taken by 1 or more States 22

on the manufacture, processing, distribution 23

in commerce, or use of the substance. 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

225

•S 697 RS

‘‘(B) PREFERENCE.—Subject to paragraph 1

(2), in deciding whether to grant requests under 2

this subsection the Administrator shall give a 3

preference to requests concerning substances for 4

which the Administrator determines that restric-5

tions imposed by 1 or more States have the po-6

tential to have a significant impact on interstate 7

commerce or health or the environment. 8

‘‘(C) EXCEPTIONS.—Chemical substances 9

for which requests have been granted under this 10

subsection shall not be subject to subsection 11

(a)(3)(A)(iii) or section 18(b). 12

‘‘(2) LIMITATIONS.—In considering whether to 13

grant a request submitted under paragraph (1), the 14

Administrator shall ensure that— 15

‘‘(A) if a sufficient number of additional 16

priority requests meet the requirements of para-17

graph (1), not less than 25 percent, or more than 18

30 percent, of the cumulative number of sub-19

stances designated to undergo safety assessments 20

and safety determinations under subsections 21

(a)(2) and (b)(3) are substances designated 22

under the process and criteria pursuant to para-23

graph (1); 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

226

•S 697 RS

‘‘(B) the resources allocated to conducting 1

safety assessments and safety determinations for 2

additional priorities designated under this sub-3

section are proportionate to the number of such 4

substances relative to the total number of sub-5

stances designated to undergo safety assessments 6

and safety determinations under this section; 7

and 8

‘‘(C) the number of additional priority re-9

quests stipulated under subparagraph (A) is in 10

addition to the total number of high-priority 11

substances identified under subsections (a)(2) 12

and (b)(3). 13

‘‘(3) ADDITIONAL REVIEW OF WORK PLAN CHEMI-14

CALS FOR SAFETY ASSESSMENT AND SAFETY DETER-15

MINATION.—In the case of a request under paragraph 16

(1) with respect to a chemical substance identified by 17

the Administrator in the October 2014 Work Plan— 18

‘‘(A) the 30-percent cap specified in para-19

graph (2)(A) shall not apply and the addition of 20

Work Plan chemicals shall be at the discretion of 21

the Administrator; and 22

‘‘(B) notwithstanding paragraph (1)(C), re-23

quests for additional Work Plan chemicals under 24

this subsection shall be considered high-priority 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

227

•S 697 RS

chemicals subject to section 18(b) but not sub-1

section (a)(3)(A)(iii). 2


‘‘(A) IN GENERAL.—The public shall be pro-4

vided notice and an opportunity to comment on 5

requests submitted under this subsection. 6

‘‘(B) DECISION BY ADMINISTRATOR.—Not 7

later than 180 days after the date on which the 8

Administrator receives a request under this sub-9

section, the Administrator shall decide whether 10

or not to grant the request. 11

‘‘(C) ASSESSMENT AND DETERMINATION.— 12

If the Administrator grants a request under this 13

subsection, the safety assessment and safety de-14

termination— 15

‘‘(i) shall be conducted in accordance 16

with the deadlines and other requirements 17

of sections 3A(i) and 6; and 18

‘‘(ii) shall not be expedited or otherwise 19

subject to special treatment relative to high- 20

priority substances designated pursuant to 21

subsection (b)(3) that are undergoing safety 22

assessments and safety determinations.’’. 23


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

228

•S 697 RS

SEC. 7. NEW CHEMICALS AND SIGNIFICANT NEW USES. 1



(1) by striking the section designation and head-4

ing and inserting the following: 5

‘‘SEC. 5. NEW CHEMICALS AND SIGNIFICANT NEW USES.’’; 6

(2) by striking subsection (b); 7

(3) by redesignating subsection (a) as subsection 8

(b); 9

(4) by redesignating subsection (i) as subsection 10

(a) and moving the subsection so as to appear at the 11

beginning of the section; 12

(5) in subsection (b) (as so redesignated)— 13

(A) in the subsection heading, by striking 14

‘‘IN GENERAL’’ and inserting ‘‘NOTICES’’; 15



graph (A), by striking ‘‘subsection (h)’’ and 18

inserting ‘‘paragraph (3) and subsection 19

(h)’’; and 20

(ii) in the matter following subpara-21

graph (B)— 22

(I) by striking ‘‘subsection (d)’’ 23

and inserting ‘‘subsection (c)’’; and 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

229

•S 697 RS

(II) by striking ‘‘and such person 1

complies with any applicable require-2

ment of subsection (b)’’; and 3

(C) by adding at the end the following: 4

‘‘(3) ARTICLE CONSIDERATION.—The Adminis-5

trator may require the notification for the import or 6

processing of a chemical substance as part of an arti-7

cle or category of articles under paragraph (1)(B) if 8

the Administrator makes an affirmative finding in a 9

rule under paragraph (2) that the reasonable poten-10

tial for exposure to the chemical substance through the 11

article or category of articles subject to the rule war-12

rants notification.’’; 13

(6) by redesignating subsections (c) and (d) as 14

subsections (d) and (c), respectively, and moving sub-15

section (c) (as so redesigned) so as appear after sub-16

section (b) (as redesignated by paragraph (3)); 17

(7) in subsection (c) (as so redesignated)— 18

(A) by striking paragraph (1) and inserting 19

the following: 20

‘‘(1) IN GENERAL.—The notice required by sub-21

section (b) shall include, with respect to a chemical 22

substance— 23


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

230

•S 697 RS

‘‘(A) the information required by sections 1

720.45 and 720.50 of title 40, Code of Federal 2

Regulations (or successor regulations); and 3

‘‘(B) information regarding conditions of 4

use and reasonably anticipated exposures.’’; 5



graph (A)— 8

(I) by striking ‘‘subsection (a)’’ 9

and inserting ‘‘subsection (b)’’; and 10

(II) by striking ‘‘or of data under 11


(ii) in subparagraph (A), by adding 13

‘‘and’’ after the semicolon at the end; 14

(iii) in subparagraph (B), by striking 15

‘‘; and’’ and inserting a period; and 16

(iv) by striking subparagraph (C); and 17

(C) in paragraph (3), by striking ‘‘sub-18

section (a) and for which the notification period 19

prescribed by subsection (a), (b), or (c)’’ and in-20

serting ‘‘subsection (b) and for which the notifi-21

cation period prescribed by subsection (b) or 22

(d)’’; 23

(8) by striking subsection (d) (as redesignated by 24

paragraph (6)) and inserting the following: 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

231

•S 697 RS

‘‘(d) REVIEW OF NOTICE.— 1

‘‘(1) INITIAL REVIEW.— 2


graph (B), not later than 90 days after the date 4

of receipt of a notice submitted under subsection 5

(b), the Administrator shall— 6

‘‘(i) conduct an initial review of the 7

notice; 8

‘‘(ii) as needed, develop a profile of the 9

relevant chemical substance and the poten-10

tial for exposure to humans and the envi-11

ronment; and 12

‘‘(iii) make any necessary determina-13

tion under paragraph (3). 14

‘‘(B) EXTENSION.—Except as provided in 15

paragraph (5), the Administrator may extend 16

the period described in subparagraph (A) for 17

good cause for 1 or more periods, the total of 18

which shall be not more than 90 days. 19

‘‘(2) INFORMATION SOURCES.—In evaluating a 20

notice under paragraph (1), the Administrator shall 21

take into consideration— 22

‘‘(A) any relevant information identified in 23

subsection (c)(1); and 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

232

•S 697 RS

‘‘(B) any other relevant additional informa-1

tion available to the Administrator. 2

‘‘(3) DETERMINATIONS.—Before the end of the 3

applicable period for review under paragraph (1), 4

based on the information described in paragraph (2), 5

and subject to section 18(g), the Administrator shall 6

determine that— 7

‘‘(A) the relevant chemical substance or sig-8

nificant new use is not likely to meet the safety 9


take appropriate action under paragraph (4); 11

‘‘(B) the relevant chemical substance or sig-12

nificant new use is likely to meet the safety 13


allow the review period to expire without addi-15

tional restrictions; or 16





graphs (4) and (5). 21

‘‘(4) RESTRICTIONS.— 22

‘‘(A) DETERMINATION BY ADMINIS-23

TRATOR.— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

233

•S 697 RS


trator makes a determination under sub-2

paragraph (A) or (C) of paragraph (3) with 3

respect to a notice submitted under sub-4

section (b)— 5

‘‘(I) the Administrator, before the 6

end of the applicable period for review 7

under paragraph (1) and by consent 8

agreement or order, as appropriate, 9

shall prohibit or otherwise restrict the 10

manufacture, processing, use, distribu-11

tion in commerce, or disposal (as ap-12

plicable) of the chemical substance, or 13

of the chemical substance for a signifi-14

cant new use, without compliance with 15

the restrictions specified in the consent 16

agreement or order that the Adminis-17

trator determines are sufficient to en-18

sure that the chemical substance or sig-19

nificant new use is likely to meet the 20

safety standard; and 21

‘‘(II) no person may commence 22

manufacture of the chemical substance, 23

or manufacture or processing of the 24



alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

234

•S 697 RS

new use, except in compliance with the 1

restrictions specified in the consent 2

agreement or order. 3

‘‘(ii) LIKELY TO MEET STANDARD.—If 4

the Administrator makes a determination 5

under subparagraph (B) of paragraph (3) 6

with respect to a chemical substance or sig-7

nificant new use for which a notice was 8

submitted under subsection (b), at the end 9

of the applicable period for review under 10

paragraph (1), the submitter of the notice 11

may commence manufacture for commercial 12

purposes of the chemical substance or man-13

ufacture or processing of the chemical sub-14

stance for a significant new use. 15

‘‘(B) REQUIREMENTS.—Not later than 90 16

days after issuing a consent agreement or order 17


shall— 19

‘‘(i) take into consideration whether to 20

promulgate a rule pursuant to subsection 21

(b)(2) that identifies as a significant new 22

use any manufacturing, processing, use, dis-23

tribution in commerce, or disposal of the 24

chemical substance, or of the chemical sub-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

235

•S 697 RS

stance for a new use, that is not in compli-1

ance with the restrictions imposed by the 2

consent agreement or order; and 3

‘‘(ii)(I) initiate a rulemaking described 4

in clause (i); or 5

‘‘(II) publish a statement describing 6

the reasons of the Administrator for not ini-7

tiating a rulemaking. 8

‘‘(C) INCLUSIONS.—A prohibition or other 9

restriction under subparagraph (A) may include, 10

as appropriate— 11

‘‘(i) subject to section 18(g), a require-12

ment that a chemical substance shall be 13

marked with, or accompanied by, clear and 14

adequate minimum warnings and instruc-15

tions with respect to use, distribution in 16

commerce, or disposal, or any combination 17

of those activities, with the form and con-18

tent of the minimum warnings and instruc-19

tions to be prescribed by the Administrator 20

‘‘(ii) a requirement that manufacturers 21

or processors of the chemical substance 22

shall— 23

‘‘(I) make and retain records of 24

the processes used to manufacture or 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

236

•S 697 RS

process, as applicable, the chemical 1

substance; or 2

‘‘(II) monitor or conduct such ad-3

ditional tests as are reasonably nec-4

essary to address potential risks from 5

the manufacture, processing, distribu-6

tion in commerce, use, or disposal, as 7

applicable, of the chemical substance, 8

subject to section 4; 9

‘‘(iii) a restriction on the quantity of 10

the chemical substance that may be manu-11

factured, processed, or distributed in com-12

merce— 13


‘‘(II) for a particular use; 15

‘‘(iv) a prohibition or other restriction 16

of— 17

‘‘(I) the manufacture, processing, 18

or distribution in commerce of the 19


new use; 21

‘‘(II) any method of commercial 22

use of the chemical substance; or 23

‘‘(III) any method of disposal of 24

the chemical substance; or 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

237

•S 697 RS

‘‘(v) a prohibition or other restriction 1

on the manufacture, processing, or distribu-2

tion in commerce of the chemical sub-3

stance— 4


‘‘(II) for a particular use. 6

‘‘(D) PERSISTENT AND BIOACCUMULATIVE 7

SUBSTANCES.—For a chemical substance the Ad-8

ministrator determines ranks high for persistence 9

and bioaccumulation, the Administrator shall, in 10

selecting among prohibitions and other restric-11

tions that the Administrator determines are suf-12

ficient to ensure that the chemical substance is 13

likely to meet the safety standard, reduce poten-14

tial exposure to the substance to the maximum 15

extent practicable. 16

‘‘(E) WORKPLACE EXPOSURES.—The Ad-17



Health prior to adopting any prohibition or 20

other restriction under this subsection to address 21

workplace exposures. 22

‘‘(F) DEFINITION OF REQUIREMENT.—For 23

purposes of this Act, the term ‘requirement’ as 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

238

•S 697 RS

used in this section does not displace common 1

law. 2

‘‘(5) ADDITIONAL INFORMATION.—If the Admin-3

istrator determines under paragraph (3)(C) that ad-4

ditional information is necessary to conduct a review 5

under this subsection, the Administrator— 6

‘‘(A) shall provide an opportunity for the 7

submitter of the notice to submit the additional 8

information; 9

‘‘(B) may, by agreement with the submitter, 10

extend the review period for a reasonable time to 11

allow the development and submission of the ad-12

ditional information; 13

‘‘(C) may promulgate a rule, enter into a 14


under section 4 to require the development of the 16

information; and 17

‘‘(D) on receipt of information the Adminis-18

trator finds supports the determination under 19

paragraph (3), shall promptly make the deter-20

mination.’’; 21

(9) by striking subsections (e) through (g) and 22


‘‘(e) NOTICE OF COMMENCEMENT.— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

239

•S 697 RS

‘‘(1) IN GENERAL.—Not later than 30 days after 1

the date on which a manufacturer that has submitted 2

a notice under subsection (b) commences nonexempt 3

commercial manufacture of a chemical substance, the 4

manufacturer shall submit to the Administrator a no-5

tice of commencement that identifies— 6

‘‘(A) the name of the manufacturer; and 7

‘‘(B) the initial date of nonexempt commer-8

cial manufacture. 9

‘‘(2) WITHDRAWAL.—A manufacturer or proc-10

essor that has submitted a notice under subsection (b), 11

but that has not commenced nonexempt commercial 12

manufacture or processing of the chemical substance, 13

may withdraw the notice. 14

‘‘(f) FURTHER EVALUATION.—The Administrator may 15

review a chemical substance under section 4A at any time 16

after the Administrator receives— 17

‘‘(1) a notice of commencement for a chemical 18

substance under subsection (e); or 19

‘‘(2) new information regarding the chemical 20

substance. 21

‘‘(g) TRANSPARENCY.—Subject to section 14, the Ad-22

ministrator shall make available to the public— 23

‘‘(1) all notices, determinations, consent agree-24

ments, rules, and orders of the Administrator; and 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

240

•S 697 RS

‘‘(2) all information submitted or issued under 1

this section.’’; and 2

(10) in subsection (h)— 3



graph (A), by striking ‘‘(a) or’’; and 6

(ii) in subparagraph (A), by inserting 7

‘‘, without taking into account cost or other 8

nonrisk factors’’ after ‘‘the environment’’; 9

(B) by striking paragraph (2); 10

(C) by redesignating paragraphs (3) 11


spectively; 13

(D) in paragraph (2) (as so redesignated), 14

in the matter preceding subparagraph (A), by 15

striking ‘‘subsections (a) and (b)’’ and inserting 16

‘‘subsection (b)’’; 17

(E) in paragraph (3) (as so redesignated)— 18

(i) in the first sentence, by striking 19

‘‘will not present an unreasonable risk of 20

injury to health or the environment’’ and 21

inserting ‘‘will meet the safety standard’’; 22

and 23

(ii) by striking the second sentence; 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

241

•S 697 RS

(F) in paragraph (4) (as so redesignated), 1

by striking ‘‘subsections (a) and (b)’’ and insert-2

ing ‘‘subsection (b)’’; and 3

(G) in paragraph (5) (as so redesignated), 4

in the first sentence, by striking ‘‘paragraph (1) 5

or (5)’’ and inserting ‘‘paragraph (1) or (4)’’. 6

SEC. 8. SAFETY ASSESSMENTS AND SAFETY DETERMINA-7

TIONS. 8



(1) by striking the section designation and head-11

ing and inserting the following: 12

‘‘SEC. 6. SAFETY ASSESSMENTS AND SAFETY DETERMINA-13

TIONS.’’; 14


subsections (g) and (h), respectively; 16

(3) by striking subsections (a) through (d) and 17


‘‘(a) IN GENERAL.—The Administrator— 19

‘‘(1) shall conduct a safety assessment and make 20

a safety determination of each high-priority substance 21

in accordance with subsections (b) and (c); 22

‘‘(2) shall, as soon as practicable and not later 23

than 6 months after the date on which a chemical 24

substance is designated as a high-priority substance, 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

242

•S 697 RS

define and publish the scope of the safety assessment 1

and safety determination to be conducted pursuant to 2

this section, including the hazards, exposures, condi-3

tions of use, and potentially exposed or susceptible 4

populations that the Administrator expects to con-5

sider; 6

‘‘(3) as appropriate based on the results of a 7

safety determination, shall establish restrictions pur-8

suant to subsection (d); 9

‘‘(4) shall complete a safety assessment and safe-10

ty determination not later than 3 years after the date 11

on which a chemical substance is designated as a 12

high-priority substance; 13

‘‘(5) shall promulgate a final rule pursuant to 14

subsection (d) by not later than 2 years after the date 15

on which the safety determination is completed; and 16

‘‘(6) may extend any deadline under paragraph 17

(4) or (5) for a reasonable period of time after an 18

adequate public justification, subject to the condition 19

that the aggregate length of all extensions of deadlines 20

under this subsection, plus any deferral under sub-21

section (c)(2), does not exceed 2 years. 22

‘‘(b) PRIOR ACTIONS AND NOTICE OF EXISTING INFOR-23

MATION.— 24

‘‘(1) PRIOR-INITIATED ASSESSMENTS.— 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

243

•S 697 RS

‘‘(A) IN GENERAL.—Nothing in this Act 1

prevents the Administrator from initiating a 2

safety assessment or safety determination regard-3

ing a chemical substance, or from continuing or 4

completing such a safety assessment or safety de-5

termination that was initiated before the date of 6

enactment of the Frank R. Lautenberg Chemical 7

Safety for the 21st Century Act, prior to the ef-8

fective date of the policies and procedures re-9

quired to be established by the Administrator 10

under section 3A or 4A. 11

‘‘(B) INTEGRATION OF PRIOR POLICIES AND 12

PROCEDURES.—As policies and procedures under 13

section 3A and 4A are established, to the max-14

imum extent practicable, the Administrator shall 15

integrate the policies and procedures into ongo-16

ing safety assessments and safety determinations. 17

‘‘(2) ACTIONS COMPLETED PRIOR TO COMPLE-18

TION OF POLICIES AND PROCEDURES.—Nothing in 19

this Act requires the Administrator to revise or with-20

draw a completed safety assessment, safety determina-21

tion, or rule solely because the action was completed 22

prior to the completion of a policy or procedure estab-23

lished under section 3A or 4A, and the validity of a 24

completed assessment, determination, or rule shall not 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

244

•S 697 RS

be determined based on the content of such a policy 1

or procedure. 2

‘‘(3) NOTICE OF EXISTING INFORMATION.— 3


shall, where such information is available, take 5

notice of existing information regarding hazard 6

and exposure published by other Federal agencies 7

and the National Academies and incorporate the 8

information in safety assessments and safety de-9

terminations with the objective of increasing the 10

efficiency of the safety assessments and safety de-11

terminations. 12

‘‘(B) INCLUSION OF INFORMATION.—Exist-13

ing information described in subparagraph (A) 14

should be included to the extent practicable and 15

where the Administrator determines the informa-16

tion is relevant and scientifically reliable. 17

‘‘(c) SAFETY DETERMINATIONS.— 18

‘‘(1) IN GENERAL.—Based on a review of the in-19

formation available to the Administrator, including 20

draft safety assessments submitted by interested per-21

sons, and subject to section 18, the Administrator 22

shall determine that— 23

‘‘(A) the relevant chemical substance meets 24

the safety standard; 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

245

•S 697 RS

‘‘(B) the relevant chemical substance does 1

not meet the safety standard, in which case the 2

Administrator shall, by rule under subsection 3

(d)— 4

‘‘(i) impose restrictions necessary to 5

ensure that the chemical substance meets the 6

safety standard under the conditions of use; 7

or 8

‘‘(ii) if the safety standard cannot be 9

met with the application of restrictions, ban 10

or phase out the chemical substance, as ap-11

propriate; or 12





graph (2). 17

‘‘(2) ADDITIONAL INFORMATION.—If the Admin-18

istrator determines that additional information is 19

necessary to make a safety assessment or safety deter-20

mination for a high-priority substance, the Adminis-21

trator— 22

‘‘(A) shall provide an opportunity for inter-23

ested persons to submit the additional informa-24

tion; 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

246

•S 697 RS

‘‘(B) may promulgate a rule, enter into a 1


under section 4 to require the development of the 3

information; 4

‘‘(C) may defer, for a reasonable period con-5

sistent with the deadlines described in subsection 6

(a), a safety assessment and safety determination 7

until after receipt of the information; and 8

‘‘(D) consistent with the deadlines described 9

in subsection (a), on receipt of information the 10

Administrator finds supports the safety assess-11

ment and safety determination, shall make a de-12

termination under paragraph (1). 13

‘‘(3) ESTABLISHMENT OF DEADLINE.—In re-14

questing the development or submission of informa-15

tion under this section, the Administrator shall estab-16

lish a deadline for the submission of the information. 17

‘‘(d) RULE.— 18

‘‘(1) IMPLEMENTATION.—If the Administrator 19

makes a determination under subsection (c)(1)(B) 20

with respect to a chemical substance, the Adminis-21

trator shall promulgate a rule establishing restrictions 22

necessary to ensure that the chemical substance meets 23

the safety standard. 24

‘‘(2) SCOPE.— 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

247

•S 697 RS

‘‘(A) IN GENERAL.—The rule promulgated 1

pursuant to this subsection— 2

‘‘(i) may apply to mixtures containing 3

the chemical substance, as appropriate; 4

‘‘(ii) shall include dates by which com-5

pliance is mandatory, which— 6

‘‘(I) shall be as soon as prac-7

ticable; 8

‘‘(II) in the case of a ban or 9

phase-out of the chemical substance, 10

shall implement the ban or phase-out 11

in as short a period as practicable; 12

and 13

‘‘(III) as determined by the Ad-14

ministrator, may vary for different af-15

fected persons; and 16

‘‘(iii) shall exempt replacement parts 17

that are manufactured prior to the effective 18

date of the rule for articles that are first 19

manufactured prior to the effective date of 20

the rule unless the Administrator finds the 21

replacement parts contribute significantly 22

to the identified risk; and 23

‘‘(iv) shall, in selecting among prohibi-24

tions and other restrictions, apply such pro-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

248

•S 697 RS

hibitions or other restrictions to articles 1

containing the chemical substance only to 2

the extent necessary to address the identified 3

risks in order to determine that the chem-4

ical substance meets the safety standard. 5

‘‘(B) PERSISTENT AND BIOACCUMULATIVE 6

SUBSTANCES.—For a chemical substance the Ad-7

ministrator determines ranks high for persistence 8

and bioaccumulation, the Administrator shall, in 9

selecting among prohibitions and other restric-10

tions that the Administrator determines are suf-11

ficient to ensure that the chemical substance 12

meets the safety standard, reduce exposure to the 13

substance to the maximum extent practicable. 14

‘‘(C) WORKPLACE EXPOSURES.—The Ad-15



Health before adopting any prohibition or other 18

restriction under this subsection to address work-19

place exposures. 20

‘‘(D) DEFINITION OF REQUIREMENT.—For 21

the purposes of this Act, the term ‘requirement’ 22

as used in this section does not displace common 23

law. 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

249

•S 697 RS

‘‘(3) RESTRICTIONS.—A restriction under para-1

graph (1) may include, as appropriate— 2

‘‘(A) subject to section 18, a requirement 3

that a chemical substance shall be marked with, 4

or accompanied by, clear and adequate min-5

imum warnings and instructions with respect to 6

use, distribution in commerce, or disposal, or 7

any combination of those activities, with the 8

form and content of the minimum warnings and 9

instructions to be prescribed by the Adminis-10

trator; 11

‘‘(B) a requirement that manufacturers or 12

processors of the chemical substance shall— 13

‘‘(i) make and retain records of the 14

processes used to manufacture or process the 15

chemical substance; 16

‘‘(ii) describe and apply the relevant 17

quality control procedures followed in the 18

manufacturing or processing of the sub-19

stance; or 20

‘‘(iii) monitor or conduct tests that are 21

reasonably necessary to ensure compliance 22

with the requirements of any rule under 23

this subsection; 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

250

•S 697 RS

‘‘(C) a restriction on the quantity of the 1


processed, or distributed in commerce; 3

‘‘(D) a requirement to ban or phase out, or 4

any other rule regarding, the manufacture, proc-5

essing, or distribution in commerce of the chem-6

ical substance for— 7

‘‘(i) a particular use; 8


tion in excess of a level specified by the Ad-10

ministrator; or 11

‘‘(iii) all uses; 12

‘‘(E) a restriction on the quantity of the 13


processed, or distributed in commerce for— 15

‘‘(i) a particular use; or 16


tion in excess of a level specified by the Ad-18

ministrator; 19

‘‘(F) a requirement to ban, phase out, or 20

otherwise restrict any method of commercial use 21

of the chemical substance; 22

‘‘(G) a requirement to ban, phase out, or 23

otherwise restrict any method of disposal of the 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

251

•S 697 RS

chemical substance or any article containing the 1

chemical substance; and 2

‘‘(H) a requirement directing manufactur-3

ers or processors of the chemical substance to give 4

notice of the Administrator’s determination 5

under subsection (c)(1)(B) to distributors in 6

commerce of the chemical substance and, to the 7

extent reasonably ascertainable, to other persons 8

in the chain of commerce in possession of the 9

chemical substance. 10

‘‘(4) ANALYSIS FOR RULEMAKING.— 11

‘‘(A) CONSIDERATIONS.—In deciding which 12

restrictions to impose under paragraph (3) as 13

part of developing a rule under paragraph (1), 14

the Administrator shall take into consideration, 15

to the extent practicable based on reasonably 16

available information, the quantifiable and non-17

quantifiable costs and benefits of the proposed 18

regulatory action and of the 1 or more primary 19

alternative regulatory actions considered by the 20

Administrator. 21

‘‘(B) ALTERNATIVES.—As part of the anal-22

ysis, the Administrator shall review any 1 or 23

more technically and economically feasible alter-24

natives to the chemical substance that the Ad-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

252

•S 697 RS

ministrator determines are relevant to the rule-1

making. 2

‘‘(C) PUBLIC AVAILABILITY.—In proposing 3

a rule under paragraph (1), the Administrator 4

shall make publicly available any analysis con-5

ducted under this paragraph. 6

‘‘(D) STATEMENT REQUIRED.—In making 7

final a rule under paragraph (1), the Adminis-8

trator shall include a statement describing how 9

the analysis considered under subparagraph (A) 10




may exempt 1 or more uses of a chemical sub-14

stance from any restriction in a rule promul-15

gated under paragraph (1) if the Administrator 16

determines that— 17

‘‘(i) the rule cannot be complied with, 18

without— 19

‘‘(I) harming national security; 20

‘‘(II) causing significant disrup-21

tion in the national economy due to 22

the lack of availability of a chemical 23

substance; or 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

253

•S 697 RS

‘‘(III) interfering with a critical 1

or essential use for which no tech-2

nically and economically feasible safer 3

alternative is available, taking into 4

consideration hazard and exposure; or 5

‘‘(ii) the use of the chemical substance, 6

as compared to reasonably available alter-7

natives, provides a substantial benefit to 8

health, the environment, or public safety. 9

‘‘(B) EXEMPTION ANALYSIS.—In proposing 10

a rule under paragraph (1) that includes an ex-11

emption under this paragraph, the Adminis-12

trator shall make publicly available any analysis 13

conducted under this paragraph to assess the 14

need for the exemption. 15

‘‘(C) STATEMENT REQUIRED.—In making 16

final a rule under paragraph (1) that includes 17


istrator shall include a statement describing how 19

the analysis considered under subparagraph (B) 20


‘‘(D) ANALYSIS IN CASE OF BAN OR PHASE- 22

OUT.—In determining whether an exemption 23

should be granted under this paragraph for a 24

chemical substance for which a ban or phase-out 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

254

•S 697 RS

is proposed, the Administrator shall take into 1

consideration, to the extent practicable based on 2

reasonably available information, the quantifi-3

able and nonquantifiable costs and benefits of the 4

1 or more technically and economically feasible 5

alternatives to the chemical substance most likely 6

to be used in place of the chemical substance 7

under the conditions of use if the rule is promul-8

gated. 9

‘‘(E) CONDITIONS.—As part of a rule pro-10

mulgated under paragraph (1), the Adminis-11

trator shall include conditions in any exemption 12

established under this paragraph, including rea-13

sonable recordkeeping, monitoring, and reporting 14

requirements, to the extent that the Adminis-15

trator determines the conditions are necessary to 16

protect health and the environment while achiev-17

ing the purposes of the exemption. 18

‘‘(F) DURATION.— 19


shall establish, as part of a rule under 21

paragraph (1) that contains an exemption 22

under this paragraph, a time limit on any 23

exemption for a time to be determined by 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

255

•S 697 RS

the Administrator as reasonable on a case- 1

by-case basis. 2

‘‘(ii) AUTHORITY OF ADMINIS-3

TRATOR.—The Administrator, by rule, may 4

extend, modify, or eliminate the exemption 5

if the Administrator determines, on the 6

basis of reasonably available information 7

and after adequate public justification, the 8

exemption warrants extension or is no 9

longer necessary. 10

‘‘(iii) CONSIDERATIONS.— 11

‘‘(I) IN GENERAL.—Subject to 12

subclause (II), the Administrator shall 13

issue exemptions and establish time pe-14

riods by considering factors determined 15

by the Administrator to be relevant to 16

the goals of fostering innovation and 17

the development of alternatives that 18

meet the safety standard. 19

‘‘(II) LIMITATION.—Any renewal 20

of an exemption in the case of a rule 21

requiring the ban or phase-out of a 22

chemical substance shall not exceed 5 23

years. 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

256

•S 697 RS

‘‘(e) IMMEDIATE EFFECT.—The Administrator may 1

declare a proposed rule under subsection (d)(1) to be effec-2

tive on publication of the rule in the Federal Register and 3

until the effective date of final action taken respecting the 4

rule, if— 5

‘‘(1) the Administrator determines that— 6



ical substance or mixture subject to the proposed 9

rule or any combination of those activities is 10

likely to result in a risk of serious or widespread 11

injury to health or the environment before the ef-12

fective date; and 13

‘‘(B) making the proposed rule so effective is 14

necessary to protect the public interest; and 15

‘‘(2) in the case of a proposed rule to prohibit the 16

manufacture, processing, or distribution in commerce 17

of a chemical substance or mixture because of the risk 18

determined under paragraph (1)(A), a court has 19

granted relief in an action under section 7 with re-20

spect to that risk associated with the chemical sub-21

stance or mixture. 22

‘‘(f) FINAL AGENCY ACTION.—Under this section and 23

subject to section 18— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

257

•S 697 RS

‘‘(1) a safety determination, and the associated 1

safety assessment, for a chemical substance that the 2

Administrator determines under subsection (c) meets 3

the safety standard, shall be considered to be a final 4

agency action, effective beginning on the date of 5

issuance of the final safety determination; and 6

‘‘(2) a final rule promulgated under subsection 7

(d)(1), and the associated safety assessment and safe-8

ty determination that a chemical substance does not 9

meet the safety standard, shall be considered to be a 10

final agency action, effective beginning on the date of 11

promulgation of the final rule.’’; and 12

(4) in subsection (g) (as redesignated by para-13

graph (2))— 14


(B) by redesignating paragraph (5) as 16

paragraph (4). 17

SEC. 9. IMMINENT HAZARDS. 18



(1) by striking subsection (a) and inserting the 21

following: 22

‘‘(a) CIVIL ACTIONS.— 23


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

258

•S 697 RS

‘‘(1) IN GENERAL.—The Administrator may 1

commence a civil action in an appropriate United 2

States district court for— 3

‘‘(A) seizure of an imminently hazardous 4

chemical substance or mixture or any article 5

containing the chemical substance or mixture; 6

‘‘(B) relief (as authorized by subsection (b)) 7

against any person that manufactures, processes, 8

distributes in commerce, uses, or disposes of, an 9

imminently hazardous chemical substance or 10

mixture or any article containing the chemical 11

substance or mixture; or 12

‘‘(C) both seizure described in subparagraph 13

(A) and relief described in subparagraph (B). 14

‘‘(2) RULE, ORDER, OR OTHER PROCEEDING.—A 15

civil action may be commenced under this paragraph, 16

notwithstanding— 17

‘‘(A) the existence of a decision, rule, con-18

sent agreement, or order by the Administrator 19

under section 4, 4A, 5, or 6 or title IV or VI; or 20

‘‘(B) the pendency of any administrative or 21

judicial proceeding under any provision of this 22

Act.’’; 23

(2) in subsection (b)(1), by striking ‘‘unreason-24

able’’; 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

259

•S 697 RS

(3) in subsection (d), by striking ‘‘section 6(a)’’ 1

and inserting ‘‘section 6(d)’’; and 2

(4) in subsection (f), in the first sentence, by 3

striking ‘‘and unreasonable’’. 4

SEC. 10. INFORMATION COLLECTION AND REPORTING. 5




(A) in paragraph (3)(A)(ii)(I)— 9

(i) by striking ‘‘5(b)(4)’’ and inserting 10

‘‘5’’; 11

(ii) by inserting ‘‘section 4 or’’ after 12

‘‘in effect under’’; and 13

(iii) by striking ‘‘5(e),’’ and inserting 14

‘‘5(d)(4);’’; and 15


‘‘(4) RULES.— 17

‘‘(A) DEADLINE.— 18


years after the date of enactment of the 20



shall promulgate rules requiring the main-23

tenance of records and the reporting of in-24

formation known or reasonably ascertain-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

260

•S 697 RS

able by the person making the report, in-1

cluding rules requiring processors to report 2

information, so that the Administrator has 3

the information necessary to carry out sec-4

tions 4 and 6. 5

‘‘(ii) MODIFICATION OF PRIOR 6

RULES.—In carrying out this subpara-7

graph, the Administrator may modify, as 8

appropriate, rules promulgated before the 9

date of enactment of the Frank R. Lauten-10

berg Chemical Safety for the 21st Century 11

Act. 12


pursuant to subparagraph (A)— 14

‘‘(i) may impose different reporting 15

and recordkeeping requirements on manu-16

facturers and processors; and 17

‘‘(ii) shall include the level of detail 18

necessary to be reported, including the man-19

ner by which use and exposure information 20

may be reported. 21

‘‘(C) ADMINISTRATION.—In implementing 22

the reporting and recordkeeping requirements 23

under this paragraph, the Administrator shall 24

take measures— 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

261

•S 697 RS

‘‘(i) to limit the potential for duplica-1

tion in reporting requirements; 2

‘‘(ii) to minimize the impact of the 3

rules on small manufacturers and proc-4

essors; and 5

‘‘(iii) to apply any reporting obliga-6

tions to those persons likely to have infor-7

mation relevant to the effective implementa-8

tion of this title. 9


velop guidance relating to the information required to 11

be reported under the rules promulgated under this 12

subsection.’’; 13

(2) in subsection (b), by adding at the end the 14

following: 15

‘‘(3) NOMENCLATURE.— 16

‘‘(A) IN GENERAL.—In carrying out para-17

graph (1), the Administrator shall— 18

‘‘(i) maintain the use of Class 2 no-19

menclature in use on the date of enactment 20

of the Frank R. Lautenberg Chemical Safe-21

ty for the 21st Century Act; 22

‘‘(ii) maintain the use of the Soap and 23

Detergent Association Nomenclature Sys-24

tem, published in March 1978 by the Ad-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

262

•S 697 RS

ministrator in section 1 of addendum III of 1

the document entitled ‘Candidate List of 2

Chemical Substances’, and further described 3

in the appendix A of volume I of the 1985 4

edition of the Toxic Substances Control Act 5

Substances Inventory (EPA Document No. 6

EPA–560/7–85–002a); and 7

‘‘(iii) treat all components of categories 8

that are considered to be statutory mixtures 9

under this Act as being included on the list 10

published under paragraph (1) under the 11

Chemical Abstracts Service numbers for the 12

respective categories, including, without 13

limitation— 14

‘‘(I) cement, Portland, chemicals, 15

CAS No. 65997–15–1; 16

‘‘(II) cement, alumina, chemicals, 17

CAS No. 65997–16–2; 18

‘‘(III) glass, oxide, chemicals, 19

CAS No. 65997–17–3; 20

‘‘(IV) frits, chemicals, CAS No. 21

65997–18–4; 22

‘‘(V) steel manufacture, chemicals, 23

CAS No. 65997–19–5; and 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

263

•S 697 RS

‘‘(VI) ceramic materials and 1

wares, chemicals, CAS No. 66402–68– 2

4. 3

‘‘(B) MULTIPLE NOMENCLATURE CONVEN-4

TIONS.— 5

‘‘(i) IN GENERAL.—If an existing guid-6

ance allows for multiple nomenclature con-7

ventions, the Administrator shall— 8

‘‘(I) maintain the nomenclature 9

conventions for substances; and 10

‘‘(II) develop new guidance that— 11

‘‘(aa) establishes equivalency 12

between the nomenclature conven-13

tions for chemical substances on 14

the list published under para-15

graph (1); and 16

‘‘(bb) permits persons to rely 17

on the new guidance for purposes 18

of determining whether a chemical 19

substance is on the list published 20

under paragraph (1). 21

‘‘(ii) MULTIPLE CAS NUMBERS.—For 22

any chemical substance appearing multiple 23

times on the list under different Chemical 24

Abstracts Service numbers, the Adminis-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

264

•S 697 RS

trator shall develop guidance recognizing 1

the multiple listings as a single chemical 2

substance. 3

‘‘(4) CHEMICAL SUBSTANCES IN COMMERCE.— 4

‘‘(A) RULES.— 5




the 21st Century Act, the Administrator, by 9

rule, shall require manufacturers and proc-10

essors to notify the Administrator, by not 11

later than 180 days after the date of pro-12

mulgation of the rule, of each chemical sub-13

stance on the list published under para-14

graph (1) that the manufacturer or proc-15

essor, as applicable, has manufactured or 16

processed for a nonexempt commercial pur-17

pose during the 10-year period ending on 18

the day before the date of enactment of the 19


the 21st Century Act. 21

‘‘(ii) ACTIVE SUBSTANCES.—The Ad-22

ministrator shall, pursuant to paragraph 23

(5)(A), designate chemical substances for 24

which notices are received under clause (i) 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

265

•S 697 RS

to be active substances on the list published 1

under paragraph (1). 2

‘‘(B) CONFIDENTIAL CHEMICAL SUB-3

STANCES.—The rule promulgated by the Admin-4

istrator pursuant to subparagraph (A) shall re-5

quire— 6

‘‘(i) the Administrator to maintain the 7

list under paragraph (1), which shall in-8

clude a confidential portion and a noncon-9

fidential portion consistent with this section 10

and section 14; 11

‘‘(ii) a manufacturer or processor that 12

is submitting a notice pursuant to subpara-13

graph (A) for a chemical substance on the 14

confidential portion of the list published 15

under paragraph (1) to indicate in the no-16

tice whether the manufacturer or processor 17

seeks to maintain any existing claim for 18

protection against disclosure of the specific 19

identity of the substance as confidential 20

pursuant to section 14; and 21

‘‘(iii) the substantiation of those claims 22

pursuant to section 14 and in accordance 23

with the review plan described in subpara-24

graph (C). 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

266

•S 697 RS

‘‘(C) REVIEW PLAN.—Not later than 1 year 1

after the date on which the Administrator com-2

piles the initial list of active substances pursuant 3

to subparagraph (A), the Administrator shall 4

promulgate a rule that establishes a plan to re-5

view all claims to protect the specific identities 6

of chemical substances on the confidential por-7

tion of the list published under paragraph (1) 8

that are notified pursuant to subparagraph (A) 9

or identified as active substances under sub-10

section (f)(1). 11

‘‘(D) REQUIREMENTS OF REVIEW PLAN.— 12

The review plan under subparagraph (C) shall— 13

‘‘(i) require, at the time requested by 14

the Administrator, all manufacturers or 15

processors asserting claims under subpara-16

graph (B) to substantiate the claim unless 17

the manufacturer or processor has substan-18

tiated the claim in a submission made to 19

the Administrator during the 5-year period 20

ending on the date of the request by the Ad-21

ministrator; 22

‘‘(ii) require the Administrator, in ac-23

cordance with section 14— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

267

•S 697 RS

‘‘(I) to review each substan-1

tiation— 2

‘‘(aa) submitted pursuant to 3

clause (i) to determine if the 4

claim warrants protection from 5

disclosure; and 6

‘‘(bb) submitted previously 7

by a manufacturer or processor 8

and relied on in lieu of the sub-9

stantiation required pursuant to 10

clause (i), if the substantiation 11

has not been previously reviewed 12

by the Administrator, to deter-13

mine if the claim warrants pro-14

tection from disclosure; 15

‘‘(II) approve, modify, or deny 16

each claim; and 17



disclosure information for which the 20

Administrator approves such a claim 21

for a period of 10 years, unless, prior 22

to the expiration of the period— 23




alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

268

•S 697 RS





lic; or 5



need for protection from disclosure 8

can no longer be substantiated, in 9

which case the Administrator 10

shall take the actions described in 11

section 14(g)(2); and 12

‘‘(iii) encourage manufacturers or 13

processors that have previously made claims 14

to protect the specific identities of chemical 15

substances identified as inactive pursuant 16

to subsection (f)(2) to review and either 17

withdraw or substantiate the claims. 18

‘‘(E) TIMELINE FOR COMPLETION OF RE-19

VIEWS.— 20


shall implement the review plan so as to 22

complete reviews of all claims specified in 23

subparagraph (C) not later than 5 years 24

after the date on which the Administrator 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

269

•S 697 RS

compiles the initial list of active substances 1

pursuant to subparagraph (A). 2

‘‘(ii) CONSIDERATIONS.— 3

‘‘(I) IN GENERAL.—The Adminis-4

trator may extend the deadline for 5

completion of the reviews for not more 6

than 2 additional years, after an ade-7

quate public justification, if the Ad-8

ministrator determines that the exten-9

sion is necessary based on the number 10

of applicable claims needing review 11

and the available resources. 12



goal for the number of reviews to be 15

completed over the course of implemen-16

tation of the plan. 17

‘‘(5) ACTIVE AND INACTIVE SUBSTANCES.— 18


shall maintain and keep current designations of 20

active substances and inactive substances on the 21

list published under paragraph (1). 22

‘‘(B) UPDATE.—The Administrator shall 23

update the list of chemical substances designated 24

as active substances as soon as practicable after 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

270

•S 697 RS

the date of publication of the most recent data 1

reported under— 2

‘‘(i) part 711 of title 40, Code of Fed-3

eral Regulations (or successor regulations); 4

and 5

‘‘(ii) the rules promulgated pursuant to 6

subsection (a)(4). 7

‘‘(C) CHANGE TO ACTIVE STATUS.— 8

‘‘(i) IN GENERAL.—Any person that 9

intends to manufacture or process for a 10

nonexempt commercial purpose a chemical 11

substance that is designated as an inactive 12

substance shall notify the Administrator be-13

fore the date on which the inactive sub-14

stance is manufactured or processed. 15

‘‘(ii) CONFIDENTIAL CHEMICAL IDEN-16

TITY CLAIMS.—If a person submitting a no-17

tice under clause (i) for an inactive sub-18

stance on the confidential portion of the list 19

published under paragraph (1) seeks to 20

maintain an existing claim for protection 21


the inactive substance as confidential, the 23

person shall— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

271

•S 697 RS

‘‘(I) in the notice submitted under 1

clause (i), assert the claim; and 2

‘‘(II) by not later than 30 days 3

after providing the notice under clause 4

(i), substantiate the claim. 5

‘‘(iii) ACTIVE STATUS.—On receiving a 6

notification under clause (i), the Adminis-7

trator shall— 8

‘‘(I) designate the applicable 9

chemical substance as an active sub-10

stance; 11

‘‘(II) pursuant to section 14, 12

promptly review any claim and associ-13

ated substantiation submitted pursu-14

ant to clause (ii) for protection against 15

disclosure of the specific identity of the 16

chemical substance and approve, mod-17

ify, or deny the claim; 18



disclosure the specific identity of the 21

chemical substance for which the Ad-22

ministrator approves a claim under 23

subclause (II) for a period of not less 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

272

•S 697 RS

than 10 years, unless, prior to the ex-1

piration of the period— 2







lic; or 9



need for protection from disclosure 12

can no longer be substantiated, in 13

which case the Administrator 14

shall take the actions described in 15

section 14(g)(2); and 16

‘‘(IV) pursuant to section 4A, re-17

view the priority of the chemical sub-18

stance as the Administrator determines 19

to be necessary. 20

‘‘(D) CATEGORY STATUS.—The list of inac-21

tive substances shall not be considered to be a 22

category for purposes of section 26(c). 23

‘‘(6) INTERIM LIST OF ACTIVE SUBSTANCES.— 24

Prior to the promulgation of the rule required under 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

273

•S 697 RS

paragraph (4)(A), the Administrator shall designate 1

the chemical substances reported under part 711 of 2

title 40, Code of Federal Regulations (or successor reg-3

ulations), during the reporting period that most close-4

ly preceded the date of enactment of the Frank R. 5

Lautenberg Chemical Safety for the 21st Century Act, 6

as the interim list of active substances for the pur-7

poses of section 4A. 8

‘‘(7) PUBLIC PARTICIPATION.—Subject to this 9

subsection, the Administrator shall make available to 10

the public— 11

‘‘(A) the specific identity of each chemical 12

substance on the nonconfidential portion of the 13

list published under paragraph (1) that the Ad-14

ministrator has designated as— 15

‘‘(i) an active substance; or 16

‘‘(ii) an inactive substance; 17

‘‘(B) the accession number, generic name, 18

and, if applicable, premanufacture notice case 19

number for each chemical substance on the con-20

fidential portion of the list published under 21

paragraph (1) for which a claim of confiden-22

tiality was received and approved by the Admin-23

istrator pursuant to section 14; and 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

274

•S 697 RS

‘‘(C) subject to section 14(g), the specific 1

identity of any active substance for which— 2

‘‘(i) no claim of protection against dis-3

closure of the specific identity of the active 4

substance pursuant to this subsection was 5

received; 6

‘‘(ii) a claim for protection against 7

disclosure of the specific identity of the ac-8

tive substance has been denied by the Ad-9

ministrator; or 10

‘‘(iii) the time period for protection 11


the active substance has expired. 13

‘‘(8) LIMITATION.—No person may assert a new 14

claim under this subsection for protection from disclo-15

sure of a specific identity of any active or inactive 16

chemical substance for which a notice is received 17

under paragraph (4)(A)(i) or (5)(C)(i) that is not on 18

the confidential portion of the list published under 19

paragraph (1). 20

‘‘(9) CERTIFICATION.—Under the rules promul-21

gated under this subsection, manufacturers and proc-22

essors shall be required— 23

‘‘(A) to certify that each report the manu-24

facturer or processor submits complies with the 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

275

•S 697 RS

requirements of the rule, and that any confiden-1

tiality claims are true and correct; and 2

‘‘(B) to retain a record supporting the cer-3

tification for a period of 5 years beginning on 4

the last day of the submission period.’’; 5

(3) in subsection (e)— 6

(A) by striking ‘‘Any person’’ and inserting 7

the following: 8

‘‘(1) IN GENERAL.—Any person’’; and 9


‘‘(2) APPLICABILITY.—Any person may submit 11

to the Administrator information reasonably sup-12

porting the conclusion that a chemical substance or 13

mixture presents, will present, or does not present a 14

substantial risk of injury to health and the environ-15

ment.’’; and 16

(4) in subsection (f), by striking ‘‘For purposes 17

of this section, the’’ and inserting the following: ‘‘In 18

this section: 19

‘‘(1) ACTIVE SUBSTANCE.—The term ‘active sub-20

stance’ means a chemical substance— 21

‘‘(A) that has been manufactured or proc-22

essed for a nonexempt commercial purpose at 23

any point during the 10-year period ending on 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

276

•S 697 RS

the date of enactment of the Frank R. Lauten-1

berg Chemical Safety for the 21st Century Act; 2

‘‘(B) that is added to the list published 3

under subsection (b)(1) after that date of enact-4

ment; or 5

‘‘(C) for which a notice is received under 6

subsection (b)(5)(C). 7

‘‘(2) INACTIVE SUBSTANCE.—The term ‘inactive 8

substance’ means a chemical substance on the list 9

published under subsection (b)(1) that does not meet 10

any of the criteria described in paragraph (1). 11

‘‘(3) MANUFACTURE; PROCESS.—The’’. 12

SEC. 11. RELATIONSHIP TO OTHER FEDERAL LAWS. 13




(A) in paragraph (1), in the first sen-17

tence— 18

(i) by striking ‘‘presents or will present 19

an unreasonable risk to health or the envi-20

ronment’’ and inserting ‘‘does not meet the 21

safety standard’’; and 22

(ii) by striking ‘‘such risk’’ the first 23

place it appears and inserting ‘‘the risk 24

posed by the substance or mixture’’; 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

277

•S 697 RS


lowing subparagraph (B), by striking ‘‘section 6 2

or 7’’ and inserting ‘‘section 6(d) or section 7’’; 3

and 4

(C) in paragraph (3), by striking ‘‘section 5

6 or 7’’ and inserting ‘‘section 6(d) or 7’’; 6

(2) in subsection (d), in the first sentence, by 7




‘‘(e) EXPOSURE INFORMATION.—If the Administrator 11

obtains information related to exposures or releases of a 12

chemical substance that may be prevented or reduced under 13

another Federal law, including laws not administered by 14

the Administrator, the Administrator shall make such in-15

formation available to the relevant Federal agency or office 16

of the Environmental Protection Agency.’’. 17

SEC. 12. RESEARCH, DEVELOPMENT, COLLECTION, DISSEMI-18

NATION, AND UTILIZATION OF DATA. 19


U.S.C. 2609) is amended by striking ‘‘Health, Education, 21

and Welfare’’ each place it appears and inserting ‘‘Health 22

and Human Services’’. 23


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

278

•S 697 RS

SEC. 13. EXPORTS. 1



(1) in subsection (a), by striking paragraph (2) 4

and inserting the following: 5

‘‘(2) EXCEPTION.—Paragraph (1) shall not 6

apply to any chemical substance that the Adminis-7

trator determines— 8

‘‘(A) under section 5 is not likely to meet 9

the safety standard; or 10

‘‘(B) under section 6 does not meet the safe-11

ty standard. 12

‘‘(3) WAIVERS.—For a mixture or article con-13

taining a chemical substance described in paragraph 14

(2), the Administrator may— 15

‘‘(A) determine that paragraph (1) shall not 16

apply to the mixture or article; or 17

‘‘(B) establish a threshold concentration in 18

a mixture or article at which paragraph (1) 19

shall not apply. 20

‘‘(4) TESTING.—The Administrator may require 21

testing under section 4 of any chemical substance or 22

mixture exempted from this Act under paragraph (1) 23

for the purpose of determining whether the chemical 24

substance or mixture meets the safety standard within 25

the United States.’’; 26


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

279

•S 697 RS


following: 2

‘‘(b) NOTICE.— 3

‘‘(1) IN GENERAL.—A person shall notify the Ad-4

ministrator that the person is exporting or intends to 5

export to a foreign country— 6

‘‘(A) a chemical substance or a mixture con-7

taining a chemical substance that the Adminis-8

trator has determined under section 5 is not like-9

ly to meet the safety standard and for which a 10

prohibition or other restriction has been proposed 11

or established under that section; 12

‘‘(B) a chemical substance or a mixture 13

containing a chemical substance that the Admin-14

istrator has determined under section 6 does not 15

meet the safety standard and for which a prohi-16

bition or other restriction has been proposed or 17

established under that section; 18

‘‘(C) a chemical substance for which the 19

United States is obligated by treaty to provide 20

export notification; 21

‘‘(D) a chemical substance or mixture sub-22

ject to a significant new use rule, or a prohibi-23

tion or other restriction pursuant to a rule, 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

280

•S 697 RS

order, or consent agreement in effect under this 1

Act; or 2

‘‘(E) a chemical substance or mixture for 3

which the submission of information is required 4

under section 4. 5

‘‘(2) RULES.— 6


shall promulgate rules to carry out paragraph 8

(1). 9


pursuant to subparagraph (A) shall— 11

‘‘(i) include such exemptions as the 12

Administrator determines to be appropriate, 13

which may include exemptions identified 14

under section 5(h); and 15

‘‘(ii) indicate whether, or to what ex-16

tent, the rules apply to articles containing 17


in paragraph (1). 19

‘‘(3) NOTIFICATION.—The Administrator shall 20

submit to the government of each country to which a 21

chemical substance or mixture is exported— 22

‘‘(A) for a chemical substance or mixture 23

described in subparagraph (A), (B), or (D) of 24

paragraph (1), a notice of the determination, 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

281

•S 697 RS

rule, order, consent agreement, requirement, or 1

designation; 2

‘‘(B) for a chemical substance described in 3

paragraph (1)(C), a notice that satisfies the obli-4

gation of the United States under the applicable 5

treaty; and 6

‘‘(C) for a chemical substance or mixture 7

described in paragraph (1)(E), a notice of avail-8

ability of the information on the chemical sub-9

stance or mixture submitted to the Adminis-10

trator.’’; and 11

(3) in subsection (c)— 12


(B) by redesignating paragraphs (4) 14


spectively. 16

SEC. 14. CONFIDENTIAL INFORMATION. 17



‘‘SEC. 14. CONFIDENTIAL INFORMATION. 20

‘‘(a) IN GENERAL.—Except as otherwise provided in 21

this section, the Administrator shall not disclose informa-22

tion that is exempt from disclosure pursuant to subsection 23

(a) of section 552 of title 5, United States Code, under sub-24

section (b)(4) of that section— 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

282

•S 697 RS

‘‘(1) that is reported to, or otherwise obtained by, 1

the Administrator under this Act; and 2

‘‘(2) for which the requirements of subsection (d) 3

are met. 4

‘‘(b) INFORMATION GENERALLY PROTECTED FROM 5

DISCLOSURE.—The following information specific to, and 6

submitted by, a manufacturer, processor, or distributor that 7

meets the requirements of subsections (a) and (d) shall be 8

presumed to be protected from disclosure, subject to the con-9

dition that nothing in this Act prohibits the disclosure of 10

any such information, or information that is the subject 11

of subsection (g)(3), through discovery, subpoena, other 12

court order, or any other judicial process otherwise allowed 13

under applicable Federal or State law: 14

‘‘(1) Specific information describing the proc-15

esses used in manufacture or processing of a chemical 16

substance, mixture, or article. 17

‘‘(2) Marketing and sales information. 18

‘‘(3) Information identifying a supplier or cus-19

tomer. 20

‘‘(4) Details of the full composition of a mixture 21

and the respective percentages of constituents. 22

‘‘(5) Specific information regarding the use, 23

function, or application of a chemical substance or 24

mixture in a process, mixture, or product. 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

283

•S 697 RS

‘‘(6) Specific production or import volumes of 1

the manufacturer and specific aggregated volumes 2

across manufacturers, if the Administrator determines 3

that disclosure of the specific aggregated volumes 4

would reveal confidential information. 5

‘‘(7) Except as otherwise provided in this section, 6

the specific identity of a chemical substance prior to 7

the date on which the chemical substance is first of-8

fered for commercial distribution, including the chem-9

ical name, molecular formula, Chemical Abstracts 10

Service number, and other information that would 11

identify a specific chemical substance, if— 12

‘‘(A) the specific identity was claimed as 13

confidential information at the time it was sub-14

mitted in a notice under section 5; and 15

‘‘(B) the claim— 16

‘‘(i) is not subject to an exception 17

under subsection (e); or 18

‘‘(ii) has not subsequently been with-19

drawn or found by the Administrator not to 20

warrant protection as confidential informa-21

tion under subsection (f)(2) or (g). 22

‘‘(c) INFORMATION NOT PROTECTED FROM DISCLO-23

SURE.—Notwithstanding subsections (a) and (b), the fol-24

lowing information shall not be protected from disclosure: 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

284

•S 697 RS

‘‘(1) INFORMATION FROM HEALTH AND SAFETY 1

STUDIES.— 2


graph (B), subsection (a) does not prohibit the 4

disclosure of— 5

‘‘(i) any health and safety study that 6

is submitted under this Act with respect 7

to— 8

‘‘(I) any chemical substance or 9

mixture that, on the date on which the 10

study is to be disclosed, has been of-11

fered for commercial distribution; or 12

‘‘(II) any chemical substance or 13

mixture for which— 14

‘‘(aa) testing is required 15

under section 4; or 16

‘‘(bb) a notification is re-17

quired under section 5; or 18

‘‘(ii) any information reported to, or 19

otherwise obtained by, the Administrator 20

from a health and safety study relating to 21


in subclause (I) or (II) of clause (i). 23


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

285

•S 697 RS

‘‘(B) EFFECT OF PARAGRAPH.—Nothing in 1

this paragraph authorizes the release of any in-2

formation that discloses— 3

‘‘(i) a process used in the manufac-4

turing or processing of a chemical substance 5

or mixture; or 6

‘‘(ii) in the case of a mixture, the por-7

tion of the mixture comprised by any chem-8

ical substance in the mixture. 9

‘‘(2) CERTAIN REQUESTS.—If a request is made 10

to the Administrator under section 552(a) of title 5, 11

United States Code, for information that is described 12

in paragraph (1) that is not described in paragraph 13

(1)(B), the Administrator may not deny the request 14

on the basis of section 552(b)(4) of title 5, United 15

States Code. 16

‘‘(3) OTHER INFORMATION NOT PROTECTED 17

FROM DISCLOSURE.—The following information is not 18

protected from disclosure under this section: 19

‘‘(A) For information submitted after the 20


Chemical Safety for the 21st Century Act, the 22

specific identity of a chemical substance as of the 23

date on which the chemical substance is first of-24

fered for commercial distribution, if the person 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

286

•S 697 RS

submitting the information does not meet the re-1

quirements of subsection (d). 2

‘‘(B) A safety assessment developed, or a 3

safety determination made, under section 6. 4

‘‘(C) Any general information describing 5

the manufacturing volumes, expressed as specific 6

aggregated volumes or, if the Administrator de-7

termines that disclosure of specific aggregated 8

volumes would reveal confidential information, 9

expressed in ranges. 10

‘‘(D) A general description of a process used 11

in the manufacture or processing and industrial, 12

commercial, or consumer functions and uses of a 13

chemical substance, mixture, or article con-14

taining a chemical substance or mixture, includ-15

ing information specific to an industry or indus-16

try sector that customarily would be shared with 17

the general public or within an industry or in-18

dustry sector. 19

‘‘(4) MIXED CONFIDENTIAL AND NONCONFIDEN-20

TIAL INFORMATION .—Any information that is other-21

wise eligible for protection under this section and con-22

tained in a submission of information described in 23

this subsection shall be protected from disclosure, if 24

the submitter complies with subsection (d), subject to 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

287

•S 697 RS

the condition that information in the submission that 1

is not eligible for protection against disclosure shall 2

be disclosed. 3

‘‘(5) BAN OR PHASE-OUT.—If the Administrator 4

promulgates a rule pursuant to section 6(d) that es-5

tablishes a ban or phase-out of the manufacture, proc-6

essing, or distribution in commerce of a chemical sub-7

stance, subject to paragraphs (2), (3), and (4) of sub-8

section (g), any protection from disclosure provided 9

under this section with respect to the specific identity 10

of the chemical substance and other information relat-11

ing to the chemical substance shall no longer apply. 12

‘‘(d) REQUIREMENTS FOR CONFIDENTIALITY 13

CLAIMS.— 14

‘‘(1) ASSERTION OF CLAIMS.— 15

‘‘(A) IN GENERAL.—A person seeking to 16

protect any information submitted under this 17

Act from disclosure (including information de-18

scribed in subsection (b)) shall assert to the Ad-19

ministrator a claim for protection concurrent 20

with submission of the information, in accord-21

ance with such rules regarding a claim for pro-22

tection from disclosure as the Administrator has 23

promulgated or may promulgate pursuant to 24

this title. 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

288

•S 697 RS

‘‘(B) INCLUSION.—An assertion of a claim 1

under subparagraph (A) shall include a state-2

ment that the person has— 3

‘‘(i) taken reasonable measures to pro-4

tect the confidentiality of the information; 5

‘‘(ii) determined that the information 6

is not required to be disclosed or otherwise 7

made available to the public under any 8

other Federal law; 9

‘‘(iii) a reasonable basis to conclude 10

that disclosure of the information is likely 11

to cause substantial harm to the competitive 12

position of the person; and 13

‘‘(iv) a reasonable basis to believe that 14

the information is not readily discoverable 15

through reverse engineering. 16

‘‘(C) SPECIFIC CHEMICAL IDENTITY.—In 17

the case of a claim under subparagraph (A) for 18

protection against disclosure of a specific chem-19

ical identity, the claim shall include a struc-20

turally descriptive generic name for the chemical 21

substance that the Administrator may disclose to 22

the public, subject to the condition that the ge-23

neric name shall— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

289

•S 697 RS

‘‘(i) conform with guidance prescribed 1

by the Administrator under paragraph 2

(3)(A); and 3

‘‘(ii) describe the chemical structure of 4

the substance as specifically as practicable 5

while protecting those features of the chem-6

ical structure— 7

‘‘(I) that are considered to be con-8

fidential; and 9

‘‘(II) the disclosure of which 10

would be likely to harm the competitive 11

position of the person. 12

‘‘(D) PUBLIC INFORMATION.—No person 13

may assert a claim under this section for protec-14

tion from disclosure of information that is al-15

ready publicly available. 16

‘‘(2) ADDITIONAL REQUIREMENTS FOR CON-17

FIDENTIALITY CLAIMS.—Except for information de-18

scribed in paragraphs (1) through (7) of subsection 19

(b), a person asserting a claim to protect information 20

from disclosure under this Act shall substantiate the 21

claim, in accordance with the rules promulgated and 22

guidance issued by the Administrator. 23


velop guidance regarding— 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

290

•S 697 RS

‘‘(A) the determination of structurally de-1

scriptive generic names, in the case of claims for 2

the protection against disclosure of specific chem-3

ical identity; and 4

‘‘(B) the content and form of the statements 5

of need and agreements required under para-6

graphs (4), (5), and (6) of subsection (e). 7

‘‘(4) CERTIFICATION.—An authorized official of 8

a person described in paragraph (1)(A) shall certify 9

that the information that has been submitted is true 10

and correct. 11

‘‘(e) EXCEPTIONS TO PROTECTION FROM DISCLO-12

SURE.—Information described in subsection (a)— 13

‘‘(1) shall be disclosed if the information is to be 14

disclosed to an officer or employee of the United 15

States in connection with the official duties of the of-16

ficer or employee— 17

‘‘(A) under any law for the protection of 18

health or the environment; or 19

‘‘(B) for a specific law enforcement purpose; 20


disclosed to a contractor of the United States and em-22

ployees of that contractor— 23

‘‘(A) if, in the opinion of the Administrator, 24

the disclosure is necessary for the satisfactory 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

291

•S 697 RS

performance by the contractor of a contract with 1

the United States for the performance of work in 2

connection with this Act; and 3

‘‘(B) subject to such conditions as the Ad-4

ministrator may specify; 5

‘‘(3) shall be disclosed if the Administrator deter-6

mines that disclosure is necessary to protect health or 7

the environment; 8


disclosed to a State or political subdivision of a State, 10

on written request, for the purpose of development, 11

administration, or enforcement of a law, if— 12

‘‘(A) 1 or more applicable agreements with 13

the Administrator that conform with the guid-14

ance issued under subsection (d)(3)(B) ensure 15

that the recipient will take appropriate meas-16

ures, and has adequate authority, to maintain 17

the confidentiality of the information in accord-18

ance with procedures comparable to the proce-19

dures used by the Administrator to safeguard the 20

information; and 21

‘‘(B) the Administrator notifies the person 22

that submitted the information that the informa-23

tion has been disclosed to the State or political 24

subdivision of a State; 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

292

•S 697 RS

‘‘(5) shall be disclosed if a health or environ-1

mental professional employed by a Federal or State 2

agency or a treating physician or nurse in a non-3

emergency situation provides a written statement of 4

need and agrees to sign a written confidentiality 5

agreement with the Administrator, subject to the con-6

ditions that— 7

‘‘(A) the statement of need and confiden-8

tiality agreement shall conform with the guid-9

ance issued under subsection (d)(3)(B); 10

‘‘(B) the written statement of need shall be 11

a statement that the person has a reasonable 12

basis to suspect that— 13

‘‘(i) the information is necessary for, 14

or will assist in— 15

‘‘(I) the diagnosis or treatment of 16

1 or more individuals; or 17

‘‘(II) responding to an environ-18

mental release or exposure; and 19

‘‘(ii) 1 or more individuals being diag-20

nosed or treated have been exposed to the 21

chemical substance concerned, or an envi-22

ronmental release or exposure has occurred; 23

and 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

293

•S 697 RS

‘‘(C) the confidentiality agreement shall 1

provide that the person will not use the informa-2

tion for any purpose other than the health or en-3

vironmental needs asserted in the statement of 4

need, except as otherwise may be authorized by 5

the terms of the agreement or by the person sub-6

mitting the information to the Administrator, 7

except that nothing in this Act prohibits the dis-8

closure of any such information through dis-9

covery, subpoena, other court order, or any other 10

judicial process otherwise allowed under applica-11

ble Federal or State law; 12

‘‘(6) shall be disclosed if in the event of an emer-13

gency, a treating physician, nurse, agent of a poison 14

control center, public health or environmental official 15

of a State or political subdivision of a State, or first 16

responder (including any individual duly authorized 17

by a Federal agency, State, or political subdivision of 18

a State who is trained in urgent medical care or 19

other emergency procedures, including a police officer, 20

firefighter, or emergency medical technician) requests 21

the information, subject to the conditions that— 22

‘‘(A) the treating physician, nurse, agent, 23

public health or environmental official of a State 24

or a political subdivision of a State, or first re-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

294

•S 697 RS

sponder shall have a reasonable basis to suspect 1

that— 2

‘‘(i) a medical or public health or envi-3

ronmental emergency exists; 4

‘‘(ii) the information is necessary for, 5

or will assist in, emergency or first-aid di-6

agnosis or treatment; or 7

‘‘(iii) 1 or more individuals being di-8

agnosed or treated have likely been exposed 9

to the chemical substance concerned, or a se-10

rious environmental release of or exposure 11

to the chemical substance concerned has oc-12

curred; 13

‘‘(B) if requested by the person submitting 14

the information to the Administrator, the treat-15

ing physician, nurse, agent, public health or en-16

vironmental official of a State or a political sub-17

division of a State, or first responder shall, as 18

described in paragraph (5)— 19

‘‘(i) provide a written statement of 20

need; and 21

‘‘(ii) agree to sign a confidentiality 22

agreement; and 23

‘‘(C) the written confidentiality agreement 24

or statement of need shall be submitted as soon 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

295

•S 697 RS

as practicable, but not necessarily before the in-1

formation is disclosed; 2

‘‘(7) may be disclosed if the Administrator deter-3

mines that disclosure is relevant in a proceeding 4

under this Act, subject to the condition that the disclo-5

sure shall be made in such a manner as to preserve 6

confidentiality to the maximum extent practicable 7

without impairing the proceeding; 8


disclosed, on written request of any duly authorized 10

congressional committee, to that committee; or 11

‘‘(9) shall be disclosed if the information is re-12

quired to be disclosed or otherwise made public under 13

any other provision of Federal law. 14

‘‘(f) DURATION OF PROTECTION FROM DISCLOSURE.— 15

‘‘(1) IN GENERAL.— 16

‘‘(A) INFORMATION PROTECTED FROM DIS-17

CLOSURE.—Subject to paragraph (2), the Ad-18

ministrator shall protect from disclosure infor-19

mation that meets the requirements of subsection 20

(d) for a period of 10 years, unless, prior to the 21

expiration of the period— 22

‘‘(i) an affected person notifies the Ad-23

ministrator that the person is withdrawing 24

the confidentiality claim, in which case the 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

296

•S 697 RS

Administrator shall promptly make the in-1

formation available to the public; or 2

‘‘(ii) the Administrator otherwise be-3

comes aware that the need for protection 4

from disclosure can no longer be substan-5

tiated, in which case the Administrator 6

shall take the actions described in subsection 7

(g)(2). 8

‘‘(B) EXTENSIONS.— 9

‘‘(i) IN GENERAL.—Not later than the 10

date that is 60 days before the expiration of 11

the period described in subparagraph (A), 12

the Administrator shall provide to the per-13

son that asserted the claim a notice of the 14

impending expiration of the period. 15

‘‘(ii) STATEMENT.— 16

‘‘(I) IN GENERAL.—Not later than 17

the date that is 30 days before the expi-18

ration of the period described in sub-19

paragraph (A), a person reasserting 20

the relevant claim shall submit to the 21

Administrator a statement substan-22

tiating, in accordance with subsection 23

(d)(2), the need to extend the period. 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

297

•S 697 RS

‘‘(II) ACTION BY ADMINIS-1

TRATOR.—Not later than the date that 2

is 30 days after the date of receipt of 3

a statement under subclause (I), the 4

Administrator shall— 5

‘‘(aa) review the request; 6

‘‘(bb) make a determination 7

regarding whether the information 8

for which the request is made con-9

tinues to meet the relevant cri-10

teria established under this sec-11

tion; and 12

‘‘(cc)(AA) grant an extension 13

of not more than 10 years; or 14

‘‘(BB) deny the claim. 15

‘‘(C) NO LIMIT ON NUMBER OF EXTEN-16

SIONS.—There shall be no limit on the number 17

of extensions granted under subparagraph (B), if 18

the Administrator determines that the relevant 19

statement under subparagraph (B)(ii)(I)— 20

‘‘(i) establishes the need to extend the 21

period; and 22

‘‘(ii) meets the requirements established 23

by the Administrator. 24

‘‘(2) REVIEW AND RESUBSTANTIATION.— 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

298

•S 697 RS

‘‘(A) DISCRETION OF ADMINISTRATOR.—The 1

Administrator may review, at any time, a claim 2

for protection against disclosure under subsection 3

(a) for information submitted to the Adminis-4

trator regarding a chemical substance and re-5

quire any person that has claimed protection for 6

that information, whether before, on, or after the 7


Chemical Safety for the 21st Century Act, to 9

withdraw or reassert and substantiate or re-10

substantiate the claim in accordance with this 11

section— 12

‘‘(i) after the chemical substance is 13

identified as a high-priority substance 14

under section 4A; 15

‘‘(ii) for any chemical substance for 16

which the Administrator has made a deter-17

mination under section 6(c)(1)(C); 18

‘‘(iii) for any inactive chemical sub-19

stance identified under section 8(b)(5); or 20

‘‘(iv) in limited circumstances, if the 21

Administrator determines that disclosure of 22

certain information currently protected 23

from disclosure would assist the Adminis-24

trator in conducting safety assessments and 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

299

•S 697 RS

safety determinations under subsections (b) 1

and (c) of section 6 or promulgating rules 2

pursuant to section 6(d), subject to the con-3

dition that the information shall not be dis-4

closed unless the claimant withdraws the 5

claim or the Administrator determines that 6

the information does not meet the require-7

ments of subsection (d). 8

‘‘(B) REVIEW REQUIRED.—The Adminis-9

trator shall review a claim for protection from 10

disclosure under subsection (a) for information 11

submitted to the Administrator regarding a 12

chemical substance and require any person that 13

has claimed protection for that information, 14

whether before, on, or after the date of enactment 15

of the Frank R. Lautenberg Chemical Safety for 16

the 21st Century Act, to withdraw or reassert 17

and substantiate or resubstantiate the claim in 18

accordance with this section— 19

‘‘(i) as necessary to comply with a re-20

quest for information received by the Ad-21

ministrator under section 552 of title 5, 22

United States Code; 23

‘‘(ii) if information available to the 24

Administrator provides a basis that the re-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

300

•S 697 RS

quirements of section 552(b)(4) of title 5, 1

United States Code, are no longer met; or 2

‘‘(iii) for any substance for which the 3

Administrator has made a determination 4

under section 6(c)(1)(B). 5

‘‘(C) ACTION BY RECIPIENT.—If the Admin-6

istrator makes a request under subparagraph (A) 7

or (B), the recipient of the request shall— 8

‘‘(i) reassert and substantiate or re-9

substantiate the claim; or 10

‘‘(ii) withdraw the claim. 11

‘‘(D) PERIOD OF PROTECTION.—Protection 12

from disclosure of information subject to a claim 13

that is reviewed and approved by the Adminis-14

trator under this paragraph shall be extended for 15

a period of 10 years from the date of approval, 16

subject to any subsequent request by the Admin-17

istrator under this paragraph. 18

‘‘(3) UNIQUE IDENTIFIER.—The Administrator 19

shall— 20

‘‘(A)(i) develop a system to assign a unique 21

identifier to each specific chemical identity for 22

which the Administrator approves a request for 23

protection from disclosure, other than a specific 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

301

•S 697 RS

chemical identity or structurally descriptive ge-1

neric term; and 2

‘‘(ii) apply that identifier consistently to all 3

information relevant to the applicable chemical 4

substance; 5

‘‘(B) annually publish and update a list of 6

chemical substances, referred to by unique identi-7

fier, for which claims to protect the specific 8

chemical identity from disclosure have been ap-9

proved, including the expiration date for each 10

such claim; 11

‘‘(C) ensure that any nonconfidential infor-12

mation received by the Administrator with re-13

spect to such a chemical substance during the pe-14

riod of protection from disclosure— 15

‘‘(i) is made public; and 16

‘‘(ii) identifies the chemical substance 17

using the unique identifier; and 18

‘‘(D) for each claim for protection of specific 19

chemical identity that has been denied by the 20

Administrator on expiration of the period for 21

appeal under subsection (g)(4), that has expired, 22

or that has been withdrawn by the submitter, 23

provide public access to the specific chemical 24

identity clearly linked to all nonconfidential in-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

302

•S 697 RS

formation received by the Administrator with re-1

spect to the chemical substance. 2

‘‘(g) DUTIES OF ADMINISTRATOR.— 3

‘‘(1) DETERMINATION.— 4


subsection (b), the Administrator shall, subject to 6

subparagraph (C), not later than 90 days after 7

the receipt of a claim under subsection (d), and 8

not later than 30 days after the receipt of a re-9

quest for extension of a claim under subsection 10

(f), review and approve, modify, or deny the 11

claim or request. 12

‘‘(B) DENIAL OR MODIFICATION.— 13

‘‘(i) IN GENERAL.—Except as provided 14

in subsections (c) and (f), the Administrator 15

shall deny a claim to protect a chemical 16

identity from disclosure only if the person 17

that has submitted the claim fails to meet 18

the requirements of subsections (a) and (d). 19

‘‘(ii) REASONS FOR DENIAL OR MODI-20

FICATION.—The Administrator shall pro-21

vide to a person that has submitted a claim 22

described in clause (i) a written statement 23

of the reasons for the denial or modification 24

of the claim. 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

303

•S 697 RS

‘‘(C) SUBSETS.—The Administrator shall— 1

‘‘(i) except for claims described in sub-2

section (b)(7), review all claims under this 3

section for the protection against disclosure 4

of the specific identity of a chemical sub-5

stance; and 6

‘‘(ii) review a representative subset, 7

comprising at least 25 percent, of all other 8

claims for protection against disclosure. 9

‘‘(D) EFFECT OF FAILURE TO ACT.—The 10

failure of the Administrator to make a decision 11

regarding a claim for protection against disclo-12

sure or extension under this section shall not be 13

the basis for denial or elimination of a claim for 14

protection against disclosure. 15

‘‘(2) NOTIFICATION.— 16


subparagraph (B) and subsections (c), (e), and 18

(f), if the Administrator denies or modifies a 19

claim under paragraph (1), or promulgates a 20

rule under section 6(d) establishing a ban or 21

phase-out of a chemical substance, the Adminis-22

trator shall notify, in writing and by certified 23

mail, the person that submitted the claim of the 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

304

•S 697 RS

intent of the Administrator to release the infor-1

mation. 2

‘‘(B) RELEASE OF INFORMATION.— 3

‘‘(i) IN GENERAL.—Except as provided 4

in clause (ii), the Administrator shall not 5

release information under this subsection 6

until the date that is 30 days after the date 7

on which the person that submitted the re-8

quest receives notification under subpara-9

graph (A). 10

‘‘(ii) EXCEPTIONS.— 11

‘‘(I) IN GENERAL.—For informa-12

tion under paragraph (3) or (8) of sub-13

section (e), the Administrator shall not 14

release that information until the date 15

that is 15 days after the date on which 16

the person that submitted the claim re-17

ceives a notification, unless the Admin-18

istrator determines that release of the 19

information is necessary to protect 20

against an imminent and substantial 21

harm to health or the environment, in 22

which case no prior notification shall 23

be necessary. 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

305

•S 697 RS

‘‘(II) NO NOTIFICATION.—For in-1

formation under paragraph (1), (2), 2

(6), (7), or (9) of subsection (e), no 3

prior notification shall be necessary. 4

‘‘(3) REBUTTABLE PRESUMPTION.— 5

‘‘(A) IN GENERAL.—With respect to notifi-6

cations provided by the Administrator pursuant 7

to subsection (c)(5), there shall be a rebuttable 8

presumption that the public interest in dis-9

closing confidential information related to a 10

chemical substance subject to a rule promulgated 11

under section 6(d) that establishes a ban or 12

phase-out of the manufacture, processing, or dis-13

tribution in commerce of the substance outweighs 14

the proprietary interest in maintaining the pro-15

tection from disclosure of that information. 16

‘‘(B) REQUEST FOR NONDISCLOSURE.—A 17

person that receives a notification under para-18

graph (2) with respect to the information de-19

scribed in subparagraph (A) may submit to the 20

Administrator, before the date on which the in-21

formation is to be released, a request with sup-22

porting documentation describing why the per-23

son believes some or all of that information 24

should not be disclosed. 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

306

•S 697 RS

‘‘(C) DETERMINATION BY ADMINIS-1

TRATOR.— 2


days after the Administrator receives a re-4

quest under subparagraph (B), the Admin-5

istrator shall determine, at the discretion of 6

the Administrator, whether the documenta-7

tion provided by the person making the re-8

quest rebuts or does not rebut the presump-9

tion described in subparagraph (A), for all 10

or a portion of the information that the per-11

son has requested not be disclosed. 12

‘‘(ii) OBJECTIVE.—The Administrator 13

shall make the determination with the objec-14

tive of ensuring that information relevant to 15

protection of health and the environment is 16

disclosed to the maximum extent prac-17

ticable. 18

‘‘(D) TIMING.—Not later than 30 days after 19

making the determination described in subpara-20

graph (C), the Administrator shall make public 21

the information the Administrator has deter-22

mined is not to be protected from disclosure. 23

‘‘(E) NO TIMELY REQUEST RECEIVED.—If 24

the Administrator does not receive, before the 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

307

•S 697 RS

date on which the information described in sub-1

paragraph (A) is to be released, a request pursu-2

ant to subparagraph (B), the Administrator 3

shall promptly make public all of the informa-4

tion. 5

‘‘(4) APPEALS.— 6

‘‘(A) IN GENERAL.—If a person receives a 7

notification under paragraph (2) and believes 8

disclosure of the information is prohibited under 9

subsection (a), before the date on which the infor-10

mation is to be released, the person may bring 11

an action to restrain disclosure of the informa-12

tion in— 13

‘‘(i) the United States district court of 14

the district in which the complainant re-15

sides or has the principal place of business; 16

or 17

‘‘(ii) the United States District Court 18

for the District of Columbia. 19

‘‘(B) NO DISCLOSURE.—The Administrator 20

shall not disclose any information that is the 21

subject of an appeal under this section before the 22

date on which the applicable court rules on an 23

action under subparagraph (A). 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

308

•S 697 RS

‘‘(5) ADMINISTRATION.—In carrying out this 1

subsection, the Administrator shall use the procedures 2

described in part 2 of title 40, Code of Federal Regu-3

lations (or successor regulations). 4

‘‘(h) CRIMINAL PENALTY FOR WRONGFUL DISCLO-5

SURE.— 6

‘‘(1) OFFICERS AND EMPLOYEES OF UNITED 7

STATES.— 8

‘‘(A) IN GENERAL.—Subject to paragraph 9

(2), a current or former officer or employee of the 10

United States described in subparagraph (B) 11

shall be guilty of a misdemeanor and fined 12

under title 18, United States Code, or impris-13

oned for not more than 1 year, or both. 14

‘‘(B) DESCRIPTION.—A current or former 15

officer or employee of the United States referred 16

to in subparagraph (A) is a current or former 17

officer or employee of the United States who— 18

‘‘(i) by virtue of that employment or 19

official position has obtained possession of, 20

or has access to, material the disclosure of 21

which is prohibited by subsection (a); and 22

‘‘(ii) knowing that disclosure of that 23

material is prohibited by subsection (a), 24

willfully discloses the material in any man-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

309

•S 697 RS

ner to any person not entitled to receive 1

that material. 2

‘‘(2) OTHER LAWS.—Section 1905 of title 18, 3

United States Code, shall not apply with respect to 4

the publishing, divulging, disclosure, making known 5

of, or making available, information reported or oth-6

erwise obtained under this Act. 7

‘‘(3) CONTRACTORS.—For purposes of this sub-8

section, any contractor of the United States that is 9

provided information in accordance with subsection 10

(e)(2), including any employee of that contractor, 11

shall be considered to be an employee of the United 12

States. 13

‘‘(i) APPLICABILITY.— 14

‘‘(1) IN GENERAL.—Except as otherwise provided 15

in this section, section 8, or any other applicable Fed-16

eral law, the Administrator shall have no authority— 17

‘‘(A) to require the substantiation or re-18

substantiation of a claim for the protection from 19

disclosure of information submitted to the Ad-20

ministrator under this Act before the date of en-21

actment of the Frank R. Lautenberg Chemical 22

Safety for the 21st Century Act; or 23

‘‘(B) to impose substantiation or resubstan-24

tiation requirements under this Act that are 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

310

•S 697 RS

more extensive than those required under this 1

section. 2

‘‘(2) PRIOR ACTIONS.—Nothing in this Act pre-3

vents the Administrator from reviewing, requiring 4

substantiation or resubstantiation for, or approving, 5

modifying or denying any claim for the protection 6

from disclosure of information before the effective date 7

of such rules applicable to those claims as the Admin-8

istrator may promulgate after the date of enactment 9

of the Frank R. Lautenberg Chemical Safety for the 10

21st Century Act.’’. 11

SEC. 15. PROHIBITED ACTS. 12




‘‘(1) fail or refuse to comply with— 16

‘‘(A) any rule promulgated, consent agree-17


4; 19

‘‘(B) any requirement under section 5 or 6; 20

‘‘(C) any rule promulgated, consent agree-21


5 or 6; or 23

‘‘(D) any requirement of, or any rule pro-24

mulgated or order issued pursuant to title II;’’. 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

311

•S 697 RS

SEC. 16. PENALTIES. 1



(1) in subsection (a)(1)— 4


(i) by inserting ‘‘this Act or a rule or 6

order promulgated or issued pursuant to 7

this Act, including’’ after ‘‘a provision of’’; 8

and 9

(ii) by striking ‘‘$25,000’’ and insert-10

ing ‘‘$37,500’’; and 11

(B) in the second sentence, by striking‘‘ vio-12

lation of section 15 or 409’’ and inserting ‘‘viola-13

tion of this Act’’; and 14


(A) by striking ‘‘Any person who’’ and in-16

serting the following: 17

‘‘(1) IN GENERAL.—Any person that’’; 18

(B) by striking ‘‘section 15 or 409’’ and in-19

serting ‘‘this Act’’; 20

(C) by striking ‘‘$25,000’’ and inserting 21

‘‘$50,000’’; and 22

(D) by adding at the end the following: 23

‘‘(2) IMMINENT DANGER OF DEATH OR SERIOUS 24

BODILY INJURY.— 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

312

•S 697 RS

‘‘(A) IN GENERAL.—Any person that know-1

ingly or willfully violates any provision of this 2

Act, and that knows at the time of the violation 3

that the violation places an individual in immi-4

nent danger of death or serious bodily injury, 5

shall be subject on conviction to a fine of not 6

more than $250,000, or imprisonment for not 7

more than 15 years, or both. 8

‘‘(B) ORGANIZATIONS.—An organization 9

that commits a violation described in subpara-10

graph (A) shall be subject on conviction to a fine 11

of not more than $1,000,000 for each violation. 12

‘‘(3) KNOWLEDGE OF IMMINENT DANGER OR IN-13

JURY.—For purposes of determining whether a de-14

fendant knew that the violation placed another indi-15

vidual in imminent danger of death or serious bodily 16

injury— 17

‘‘(A) the defendant shall be responsible only 18

for actual awareness or actual belief possessed; 19

and 20

‘‘(B) knowledge possessed by an individual 21

may not be attributed to the defendant.’’. 22


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

313

•S 697 RS

SEC. 17. STATE-FEDERAL RELATIONSHIP. 1


U.S.C. 2617) is amended by striking subsections (a) and 3

(b) and inserting the following: 4

‘‘(a) IN GENERAL.— 5

‘‘(1) ESTABLISHMENT OR ENFORCEMENT.—Ex-6

cept as provided in subsections (c), (d), (e), (f), and 7

(g), and subject to paragraph (2), no State or polit-8

ical subdivision of a State may establish or continue 9

to enforce any of the following: 10

‘‘(A) TESTING AND INFORMATION COLLEC-11

TION.—A statute or administrative action to re-12

quire the development of information on a chem-13

ical substance or category of substances that is 14

reasonably likely to produce the same informa-15

tion required under section 4, 5, or 6 in— 16

‘‘(i) a rule promulgated by the Admin-17

istrator; 18

‘‘(ii) a testing consent agreement en-19

tered into by the Administrator; or 20

‘‘(iii) an order issued by the Adminis-21

trator. 22

‘‘(B) CHEMICAL SUBSTANCES FOUND TO 23

MEET THE SAFETY STANDARD OR RE-24

STRICTED.—A statute or administrative action 25

to prohibit or otherwise restrict the manufacture, 26


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

314

•S 697 RS

processing, or distribution in commerce or use of 1

a chemical substance— 2

‘‘(i) found to meet the safety standard 3

and consistent with the scope of the deter-4

mination made under section 6; or 5

‘‘(ii) found not to meet the safety 6

standard, after the effective date of the rule 7

issued under section 6(d) for the substance, 8

consistent with the scope of the determina-9

tion made by the Administrator. 10

‘‘(C) SIGNIFICANT NEW USE.—A statute or 11

administrative action requiring the notification 12

of a use of a chemical substance that the Admin-13

istrator has specified as a significant new use 14

and for which the Administrator has required 15

notification pursuant to a rule promulgated 16

under section 5. 17

‘‘(2) EFFECTIVE DATE OF PREEMPTION.—Under 18

this subsection, Federal preemption of State statutes 19

and administrative actions applicable to specific sub-20

stances shall not occur until the effective date of the 21

applicable action described in paragraph (1) taken by 22

the Administrator. 23

‘‘(b) NEW STATUTES OR ADMINISTRATIVE ACTIONS 24

CREATING PROHIBITIONS OR OTHER RESTRICTIONS.— 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

315

•S 697 RS

‘‘(1) IN GENERAL.—Except as provided in sub-1

sections (c), (d), and (e), beginning on the date on 2

which the Administrator defines the scope of a safety 3

assessment and safety determination under section 4

6(a)(2) and ending on the date on which the Admin-5

istrator publishes the safety determination, no State 6

or political subdivision of a State may establish a 7

statute or administrative action prohibiting or re-8

stricting the manufacture, processing, distribution in 9

commerce or use of a chemical substance that is a 10

high-priority substance designated under section 4A. 11

‘‘(2) EFFECT OF SUBSECTION.— 12

‘‘(A) IN GENERAL.—This subsection does 13

not restrict the authority of a State or political 14

subdivision of a State to continue to enforce any 15

State statute enacted, or administrative action 16

taken, prior to the date on which the Adminis-17

trator defines the scope of a safety assessment 18

and safety determination under section 6(a)(2). 19

‘‘(B) LIMITATION.—Subparagraph (A) does 20

not allow a State or political subdivision of a 21

State to enforce any new prohibition or restric-22

tion under a State statute or administrative ac-23

tion described in that subparagraph, if the pro-24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

316

•S 697 RS

hibition or restriction is established after the 1

date described in that subparagraph. 2

‘‘(c) SCOPE OF PREEMPTION.—Federal preemption 3

under subsections (a) and (b) of State statutes and adminis-4

trative actions applicable to specific substances shall apply 5

only to— 6

‘‘(1) the chemical substances or category of sub-7

stances subject to a rule, order, or consent agreement 8

under section 4; 9

‘‘(2) the uses or conditions of use of such sub-10

stances that are identified by the Administrator as 11

subject to review in a safety assessment and included 12

in the scope of the safety determination made by the 13

Administrator for the substance, or of any rule the 14

Administrator promulgates pursuant to section 6(d); 15

or 16

‘‘(3) the uses of such substances that the Admin-17

istrator has specified as significant new uses and for 18

which the Administrator has required notification 19

pursuant to a rule promulgated under section 5. 20

‘‘(d) EXCEPTIONS.— 21

‘‘(1) NO PREEMPTION OF STATE STATUTES AND 22

ADMINISTRATIVE ACTIONS.— 23




alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

317

•S 697 RS

rule, standard of performance, safety determina-1

tion, or scientific assessment implemented pursu-2

ant to this Act, shall affect the right of a State 3

or a political subdivision of a State to adopt or 4

enforce any rule, standard of performance, safety 5

determination, scientific assessment, or any pro-6

tection for public health or the environment 7

that— 8

‘‘(i) is adopted or authorized under the 9

authority of any other Federal law or 10

adopted to satisfy or obtain authorization 11

or approval under any other Federal law; 12

‘‘(ii) implements a reporting, moni-13

toring, disclosure, or other information obli-14

gation for the chemical substance not other-15

wise required by the Administrator under 16

this Act or required under any other Fed-17

eral law; 18

‘‘(iii) is adopted pursuant to authority 19

under a law of the State or political sub-20

division of the State related to water qual-21

ity, air quality, or waste treatment or dis-22

posal, except to the extent that the action— 23

‘‘(I) imposes a restriction on the 24

manufacture, processing, distribution 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

318

•S 697 RS

in commerce, or use of a chemical sub-1

stance; and 2

‘‘(II)(aa) addresses the same haz-3

ards and exposures, with respect to the 4

same conditions of use as are included 5

in the scope of the safety determination 6

pursuant to section 6, but is incon-7

sistent with the action of the Adminis-8

trator; or 9

‘‘(bb) would cause a violation of 10

the applicable action by the Adminis-11

trator under section 5 or 6; or 12

‘‘(iv) subject to subparagraph (B), is 13

identical to a requirement prescribed by the 14

Administrator. 15

‘‘(B) IDENTICAL REQUIREMENTS.— 16

‘‘(i) IN GENERAL.—The penalties and 17

other sanctions applicable under State law 18

in the event of noncompliance with the 19

identical requirement shall be no more 20

stringent than the penalties and other sanc-21

tions available to the Administrator under 22

section 16 of this Act. 23

‘‘(ii) PENALTIES.—In the case of an 24

identical requirement, no State may assess 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

319

•S 697 RS

a penalty for a specific violation for which 1

the Administrator has already assessed a 2

penalty under section 16, and the Adminis-3

trator may not assess a penalty under sec-4

tion 16 for a specific violation for which a 5

State has already assessed a penalty. 6

‘‘(2) APPLICABILITY TO CERTAIN RULES OR OR-7

DERS.—Notwithstanding subsection (e)— 8

‘‘(A) nothing in this section shall be con-9

strued as modifying the effect under this section, 10

as in effect on the day before the effective date of 11

the Frank R. Lautenberg Chemical Safety for the 12

21st Century Act, of any rule or order promul-13

gated or issued under this Act prior to that effec-14

tive date; and 15

‘‘(B) with respect to a chemical substance or 16

mixture for which any rule or order was promul-17

gated or issued under section 6 prior to the effec-18

tive date of the Frank R. Lautenberg Chemical 19

Safety for the 21st Century Act with regards to 20

manufacturing, processing, distribution in com-21

merce, use, or disposal of a chemical substance, 22

this section (as in effect on the day before the ef-23

fective date of the Frank R. Lautenberg Chemical 24

Safety for the 21st Century Act) shall govern the 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

320

•S 697 RS

preemptive effect of any rule or order that is pro-1

mulgated or issued respecting such chemical sub-2

stance or mixture under section 6 of this Act 3

after that effective date, unless the latter rule or 4

order is with respect to a chemical substance or 5

mixture containing a chemical substance and fol-6

lows a designation of that chemical substance as 7

a high-priority substance under section 4A(b) or 8

as an additional priority for safety assessment 9

and safety determination under section 4A(c). 10

‘‘(e) PRESERVATION OF CERTAIN STATE LAW.— 11

‘‘(1) IN GENERAL.—Nothing in this Act, subject 12

to subsection (g) of this section, shall— 13

‘‘(A) be construed to preempt or otherwise 14

affect the authority of a State or political sub-15

division of a State to continue to enforce any ac-16

tion taken before August 1, 2015, under the au-17

thority of a State law that prohibits or otherwise 18

restricts manufacturing, processing, distribution 19

in commerce, use, or disposal of a chemical sub-20

stance; or 21

‘‘(B) be construed to preempt or otherwise 22

affect any action taken pursuant to a State law 23

that was in effect on August 31, 2003. 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

321

•S 697 RS

‘‘(2) EFFECT OF SUBSECTION.—This subsection 1

does not affect, modify, or alter the relationship be-2

tween State and Federal law pursuant to any other 3

Federal law. 4

‘‘(f) STATE WAIVERS.— 5

‘‘(1) DISCRETIONARY EXEMPTIONS.—Upon ap-6

plication of a State or political subdivision of a 7

State, the Administrator may by rule, exempt from 8

subsection (a), under such conditions as may be pre-9

scribed in the rule, a statute or administrative action 10

of that State or political subdivision of the State that 11

relates to the effects of, or exposure to, a chemical sub-12

stance under the conditions of use if the Adminis-13

trator determines that— 14

‘‘(A) compelling State or local conditions 15

warrant granting the waiver to protect health or 16

the environment; 17

‘‘(B) compliance with the proposed require-18

ment of the State or political subdivision of the 19

State would not unduly burden interstate com-20

merce in the manufacture, processing, distribu-21

tion in commerce, or use of a chemical substance; 22

‘‘(C) compliance with the proposed require-23

ment of the State or political subdivision of the 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

322

•S 697 RS

State would not cause a violation of any appli-1

cable Federal law, rule, or order; and 2

‘‘(D) based on the judgment of the Adminis-3

trator, the proposed requirement of the State or 4

political subdivision of the State is consistent 5

with sound objective scientific practices, the 6

weight of the evidence, and the best available 7

science. 8

‘‘(2) REQUIRED EXEMPTIONS.—Upon applica-9

tion of a State or political subdivision of a State, the 10

Administrator shall exempt from subsection (b) a 11

statute or administrative action of a State or polit-12

ical subdivision of a State that relates to the effects 13

of exposure to a chemical substance under the condi-14

tions of use if the Administrator determines that— 15

‘‘(A) compliance with the proposed require-16

ment of the State will not unduly burden inter-17

state commerce in the manufacture, processing, 18

distribution in commerce, or use of a chemical 19

substance; 20

‘‘(B) compliance with the proposed require-21

ment would not cause a violation of any appli-22

cable Federal law, rule, or order; and 23

‘‘(C) the State or political subdivision of a 24

State has a concern about the chemical substance 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

323

•S 697 RS

or use of the chemical substance based in peer- 1

reviewed science. 2

‘‘(3) DETERMINATION OF A STATE WAIVER RE-3

QUEST.—The duty of the Administrator to grant or 4

deny a waiver application shall be nondelegable and 5

shall be exercised— 6

‘‘(A) not later than 180 days after the date 7

on which an application under paragraph (1) is 8

submitted; and 9

‘‘(B) not later than 90 days after the date 10

on which an application under paragraph (2) is 11

submitted. 12

‘‘(4) FAILURE TO MAKE DETERMINATION.—If the 13

Administrator fails to make a determination under 14

paragraph (3)(B) during the 90-day period beginning 15

on the date on which an application under paragraph 16

(2) is submitted, the State statute or administrative 17

action that was the subject of the application shall 18

not be considered to be an existing statute or admin-19

istrative action for purposes of subsection (b) by rea-20

son of the failure of the Administrator to make a de-21

termination. 22

‘‘(5) NOTICE AND COMMENT.—Except in the case 23

of an application approved under paragraph (9), the 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

324

•S 697 RS

application of a State or political subdivision of the 1

State shall be subject to public notice and comment. 2

‘‘(6) FINAL AGENCY ACTION.—The decision of the 3

Administrator on the application of a State or polit-4

ical subdivision of the State shall be— 5

‘‘(A) considered to be a final agency action; 6

and 7

‘‘(B) subject to judicial review. 8

‘‘(7) DURATION OF WAIVERS.— 9


subparagraph (B), a waiver granted under para-11

graph (2) or approved under paragraph (9) shall 12

remain in effect— 13

‘‘(i) until such time as the safety as-14

sessment and safety determination is com-15

pleted; or 16

‘‘(ii) subject to subparagraph (B), 17

until judicial review of the failure of the 18

Administrator to make a determination 19

under paragraph (3) is sought under para-20

graph (8). 21

‘‘(B) REINSTATEMENT OF WAIVER.—A 22

waiver described in subparagraph (A)(ii) shall 23

again take effect upon the earlier of— 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

325

•S 697 RS

‘‘(i) the date of approval by the Ad-1

ministrator of the waiver application; 2

‘‘(ii) the effective date of a court order 3

directing the Administrator to approve the 4

waiver application; or 5

‘‘(iii) 90 days after the date on which 6

judicial review under paragraph (8) is 7

sought. 8

‘‘(8) JUDICIAL REVIEW OF WAIVERS.—Not later 9

than 60 days after the date on which the Adminis-10

trator makes a determination on an application of a 11

State or political subdivision of the State under para-12

graph (1) or (2), or not later than 60 days after the 13

date on which the Administrator fails to make a de-14

termination under paragraph (3), any person may 15

file a petition for judicial review in the United States 16

Court of Appeals for the District of Columbia Circuit, 17

which shall have exclusive jurisdiction over the deter-18

mination. 19

‘‘(9) APPROVAL.— 20


fails to meet the deadline under section 6(a)(4) 22

(including an extension granted under section 23

6(a)(6)), or the deadline established under para-24

graph (3)(B), the application of a State or polit-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

326

•S 697 RS

ical subdivision of a State under paragraph (2) 1

shall be automatically approved. 2

‘‘(B) REQUIREMENTS.—Notwithstanding 3

paragraph (6), approval of a waiver application 4

under subparagraph (A) for failure to meet the 5

deadlines under section 6(a)(4) (including an ex-6

tension granted under section 6(a)(6)) shall not 7

be considered final agency action or be subject to 8

judicial review or public notice and comment. 9

‘‘(10) JUDICIAL REVIEW OF LOW-PRIORITY DECI-10

SIONS.— 11

‘‘(A) IN GENERAL.—Not later than 60 days 12

after the publication of a designation under sec-13

tion 4A(b)(4), any person may commence a civil 14

action to challenge the designation. 15

‘‘(B) JURISDICTION.—The United States 16

Court of Appeals for the District of Columbia 17

Circuit shall have exclusive jurisdiction over a 18

civil action filed under this paragraph. 19

‘‘(g) SAVINGS.— 20

‘‘(1) NO PREEMPTION OF COMMON LAW OR STAT-21

UTORY CAUSES OF ACTION FOR CIVIL RELIEF OR 22

CRIMINAL CONDUCT.— 23




alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

327

•S 697 RS

safety standard, rule, requirement, standard of 1

performance, safety determination, or scientific 2

assessment implemented pursuant to this Act, 3

shall be construed to preempt, displace, or sup-4

plant any state or Federal common law rights or 5

any state or Federal statute creating a remedy 6

for civil relief, including those for civil damage, 7

or a penalty for a criminal conduct. 8

‘‘(B) CLARIFICATION OF NO PREEMPTION.— 9

Notwithstanding any other provision of this Act, 10

nothing in this Act, nor any amendments made 11

by this Act, shall preempt or preclude any cause 12

of action for personal injury, wrongful death, 13

property damage, or other injury based on neg-14

ligence, strict liability, products liability, failure 15

to warn, or any other legal theory of liability 16

under any State law, maritime law, or Federal 17

common law or statutory theory. 18

‘‘(2) NO EFFECT ON PRIVATE REMEDIES.— 19


nor any amendments made by this Act, nor any 21

rules, regulations, requirements, safety assess-22

ments, safety determinations, scientific assess-23

ments, or orders issued pursuant to this Act shall 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

328

•S 697 RS

be interpreted as, in either the plaintiff’s or de-1

fendant’s favor, dispositive in any civil action. 2

‘‘(B) AUTHORITY OF COURTS.—This Act 3

does not affect the authority of any court to 4

make a determination in an adjudicatory pro-5

ceeding under applicable State or Federal law 6

with respect to the admission into evidence or 7

any other use of this Act or rules, regulations, re-8

quirements, standards of performance, safety as-9

sessments, scientific assessments, or orders issued 10

pursuant to this Act.’’. 11

SEC. 18. JUDICIAL REVIEW. 12





(i) in subparagraph (A), by striking 17

‘‘section 4(a), 5(a)(2), 5(b)(4), 6(a), 6(e), or 18

8, or under title II or IV’’ and inserting 19

‘‘section 4(a), 5(d), 6(c), 6(d), 6(g), or 8, or 20

title II or IV’’; and 21

(ii) in subparagraph (B), by striking 22

‘‘an order issued under subparagraph (A) 23

or (B) of section 6(b)(1)’’ and inserting ‘‘an 24

order issued under this title’’; and 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

329

•S 697 RS

(B) in paragraph (2), in the first sentence, 1

by striking ‘‘paragraph (1)(A)’’ and inserting 2

‘‘paragraph (1)’’; and 3

(C) by striking paragraph (3); and 4

(2) in subsection (c)(1)(B)— 5

(A) in clause (i)— 6

(i) by striking ‘‘section 4(a), 5(b)(4), 7

6(a), or 6(e)’’ and inserting ‘‘section 4(a), 8

5(d), 6(d), or 6(g)’’; and 9

(ii) by striking ‘‘evidence in the rule-10

making record (as defined in subsection 11

(a)(3)) taken as a whole;’’ and inserting 12

‘‘evidence (including any matter) in the 13

rulemaking record, taken as a whole; and’’; 14

and 15

(B) by striking clauses (ii) and (iii) and 16

the matter following clause (iii) and inserting 17

the following: 18

‘‘(ii) the court may not review the con-19

tents and adequacy of any statement of 20

basis and purpose required by section 21

553(c) of title 5, United States Code, to be 22

incorporated in the rule, except as part of 23

the rulemaking record, taken as a whole.’’. 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

330

•S 697 RS

SEC. 19. CITIZENS’ PETITIONS. 1



(1) in subsection (a), by striking ‘‘an order 4

under section 5(e) or 6(b)(2)’’ and inserting ‘‘an 5

order under section 4 or 5(d)’’; and 6


(A) in paragraph (1), by striking ‘‘an order 8

under section 5(e), 6(b)(1)(A), or 6(b)(1)(B)’’ 9

and inserting ‘‘an order under section 4 or 10

5(d)’’; and 11

(B) in paragraph (4), by striking subpara-12

graph (B) and inserting the following: 13

‘‘(B) DE NOVO PROCEEDING.— 14

‘‘(i) IN GENERAL.—In an action under 15

subparagraph (A) to initiate a proceeding 16

to promulgate a rule pursuant to section 4, 17

5, 6, or 8 or issue an order under section 18

4 or 5(d), the petitioner shall be provided 19

an opportunity to have the petition consid-20

ered by the court in a de novo proceeding. 21

‘‘(ii) DEMONSTRATION.— 22

‘‘(I) IN GENERAL.—The court in a 23

de novo proceeding under this subpara-24

graph shall order the Administrator to 25

initiate the action requested by the pe-26


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

331

•S 697 RS

titioner if the petitioner demonstrates 1

to the satisfaction of the court by a 2

preponderance of the evidence that— 3

‘‘(aa) in the case of a peti-4


the issuance of a rule or order 6

under section 4, the information 7

available to the Administrator is 8

insufficient for the Administrator 9

to perform an action described in 10

section 4, 4A, 5, or 6(d); 11

‘‘(bb) in the case of a petition 12

to issue an order under section 13

5(d), there is a reasonable basis to 14

conclude that the chemical sub-15

stance is not likely to meet the 16

safety standard; 17

‘‘(cc) in the case of a petition 18

to initiate a proceeding for the 19

issuance of a rule under section 20

6(d), there is a reasonable basis to 21

conclude that the chemical sub-22

stance will not meet the safety 23

standard; or 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

332

•S 697 RS

‘‘(dd) in the case of a peti-1



tion 8, there is a reasonable basis 4

to conclude that the rule is nec-5

essary to protect health or the en-6

vironment or ensure that the 7

chemical substance meets the safe-8

ty standard. 9

‘‘(II) DEFERMENT.—The court in 10

a de novo proceeding under this sub-11

paragraph may permit the Adminis-12

trator to defer initiating the action re-13

quested by the petitioner until such 14

time as the court prescribes, if the 15

court finds that— 16

‘‘(aa) the extent of the risk to 17

health or the environment alleged 18

by the petitioner is less than the 19

extent of risks to health or the en-20

vironment with respect to which 21

the Administrator is taking action 22

under this Act; and 23

‘‘(bb) there are insufficient 24

resources available to the Admin-25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

333

•S 697 RS

istrator to take the action re-1

quested by the petitioner.’’. 2

SEC. 20. EMPLOYMENT EFFECTS. 3

Section 24(b)(2)(B)(ii) of the Toxic Substances Control 4

Act (15 U.S.C. 2623(b)(2)(B)(ii)) is amended by striking 5

‘‘section 6(c)(3),’’ and inserting ‘‘the applicable require-6

ments of this Act;’’. 7

SEC. 21. STUDIES. 8



SEC. 22. ADMINISTRATION. 11




following: 15

‘‘(b) FEES.— 16


tablish, not later than 1 year after the date of enact-18

ment of the Frank R. Lautenberg Chemical Safety for 19

the 21st Century Act, by rule— 20

‘‘(A) the payment of 1 or more reasonable 21

fees as a condition of submitting a notice or re-22

questing an exemption under section 5; 23

‘‘(B) the payment of 1 or more reasonable 24

fees by a manufacturer or processor that— 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

334

•S 697 RS

‘‘(i) is required to submit a notice pur-1

suant to the rule promulgated under section 2

8(b)(4)(A)(i) identifying a chemical sub-3

stance as active; 4

‘‘(ii) is required to submit a notice 5

pursuant to section 8(b)(5)(B)(i) changing 6

the status of a chemical substance from in-7

active to active; 8

‘‘(iii) is required to report information 9

pursuant to the rules promulgated under 10

section 8(a)(4); and 11

‘‘(iv) manufactures or processes a 12

chemical substance subject to a safety assess-13

ment and safety determination pursuant to 14

section 6. 15

‘‘(2) UTILIZATION AND COLLECTION OF FEES.— 16

The Administrator shall— 17

‘‘(A) utilize the fees collected under para-18

graph (1) only to defray costs associated with the 19

actions of the Administrator— 20

‘‘(i) to collect, process, review, provide 21

access to, and protect from disclosure (where 22

appropriate) information on chemical sub-23

stances under this Act; 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

335

•S 697 RS

‘‘(ii) to review notices and make deter-1

minations for chemical substances under 2

paragraphs (1) and (3) of section 5(d) and 3

impose any necessary restrictions under sec-4

tion 5(d)(4); 5

‘‘(iii) to make prioritization decisions 6

under section 4A; 7

‘‘(iv) to conduct and complete safety 8

assessments and determinations under sec-9

tion 6; and 10

‘‘(v) to conduct any necessary rule-11

making pursuant to section 6(d); 12

‘‘(B) insofar as possible, collect the fees de-13

scribed in paragraph (1) in advance of con-14

ducting any fee-supported activity; 15

‘‘(C) deposit the fees in the Fund established 16

by paragraph (4)(A); and 17

‘‘(D) not collect excess fees or retain a sig-18

nificant amount of unused fees. 19

‘‘(3) AMOUNT AND ADJUSTMENT OF FEES; RE-20

FUNDS.—In setting fees under this section, the Ad-21

ministrator shall— 22

‘‘(A) take into account the cost to the Ad-23

ministrator of conducting the activities described 24

in paragraph (2); 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

336

•S 697 RS

‘‘(B) prescribe lower fees for small business 1

concerns, after consultation with the Adminis-2

trator of the Small Business Administration; 3

‘‘(C) set the fees established under para-4

graph (1) at levels such that the fees will, in ag-5

gregate, provide a sustainable source of funds to 6

defray approximately 25 percent of the costs of 7

conducting the activities identified in paragraph 8

(2)(A), not to exceed $18,000,000, not including 9

fees under subparagraph (E) of this paragraph; 10

‘‘(D) reflect an appropriate balance in the 11

assessment of fees between manufacturers and 12

processors, and allow the payment of fees by con-13

sortia of manufacturers or processors; 14

‘‘(E) for substances designated as additional 15

priorities pursuant to section 4A(c), establish the 16

fee at a level sufficient to defray the full costs to 17

the Administrator of conducting the safety as-18

sessment and safety determination under section 19

6, except that for substances subject to section 20

4A(c)(3), the Administrator shall establish the fee 21

at a level sufficient to defray 50 percent of those 22

costs; 23

‘‘(F) prior to the establishment or amend-24

ment of any fees under paragraph (1), consult 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

337

•S 697 RS

and meet with parties potentially subject to the 1

fees or their representatives, subject to the condi-2

tion that no obligation under the Federal Advi-3

sory Committee Act (5 U.S.C. App.) or sub-4

chapter III of chapter 5 of title 5, United States 5

Code, is applicable with respect to such meetings; 6

‘‘(G) beginning with the fiscal year that is 7

3 years after the date of enactment of the Frank 8

R. Lautenberg Chemical Safety for the 21st Cen-9

tury Act, and every 3 years thereafter, after con-10

sultation with parties potentially subject to the 11

fees and their representatives, increase or de-12

crease the fees established under paragraph (1) 13

as necessary— 14

‘‘(i) to ensure that funds deposited in 15

the Fund are sufficient to conduct the ac-16

tivities identified in paragraph (2)(A) and 17

the full cost or 50-percent portion of the 18

costs of safety assessments and safety deter-19

minations pursuant to subparagraph (E); 20

and 21

‘‘(ii) to account for inflation; 22

‘‘(H) adjust fees established under para-23

graph (1) as necessary to vary on account of dif-24

fering circumstances, including reduced fees or 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

338

•S 697 RS

waivers in appropriate circumstances, to reduce 1

the burden on manufacturing or processing, re-2

move barriers to innovation, or where the costs 3

to the Administrator of collecting the fees exceed 4

the fee revenue anticipated to be collected; and 5

‘‘(I) if a notice submitted under section 5 is 6

refused or subsequently withdrawn, refund the fee 7

or a portion of the fee if no substantial work was 8

performed on the notice. 9

‘‘(4) TSCA IMPLEMENTATION FUND.— 10

‘‘(A) ESTABLISHMENT.—There is estab-11

lished in the Treasury of the United States a 12

fund, to be known as the ‘TSCA Implementation 13

Fund’ (referred to in this subsection as the 14

‘Fund’), consisting of— 15

‘‘(i) such amounts as are deposited in 16

the Fund under paragraph (2)(C); and 17

‘‘(ii) any interest earned on the invest-18

ment of amounts in the Fund; and 19

‘‘(iii) any proceeds from the sale or re-20

demption of investments held in the Fund. 21

‘‘(B) CREDITING AND AVAILABILITY OF 22

FEES.— 23

‘‘(i) IN GENERAL.—Fees authorized 24

under this section shall be collected and 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

339

•S 697 RS

available for obligation only to the extent 1

and in the amount provided in advance in 2

appropriations Acts, and shall be available 3

without fiscal year limitation. 4

‘‘(ii) REQUIREMENTS.—Fees collected 5

under this section shall not— 6

‘‘(I) be made available or obli-7

gated for any purpose other than to de-8

fray the costs of conducting the activi-9

ties identified in paragraph (2)(A); 10

‘‘(II) otherwise be available for 11

any purpose other than implementa-12

tion of this Act; and 13

‘‘(III) so long as amounts in the 14

Fund remain available, be subject to 15

restrictions on expenditures applicable 16

to the Federal government as a whole. 17

‘‘(C) UNUSED FUNDS.—Amounts in the 18

Fund not currently needed to carry out this sub-19

section shall be— 20

‘‘(i) maintained readily available or 21

on deposit; 22

‘‘(ii) invested in obligations of the 23

United States or guaranteed by the United 24

States; or 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

340

•S 697 RS

‘‘(iii) invested in obligations, partici-1

pations, or other instruments that are law-2

ful investments for fiduciary, trust, or pub-3

lic funds. 4

‘‘(D) MINIMUM AMOUNT OF APPROPRIA-5

TIONS.—Fees may not be assessed for a fiscal 6

year under this section unless the amount of ap-7

propriations for salaries, contracts, and expenses 8

for the functions (as in existence in fiscal year 9

2015) of the Office of Pollution Prevention and 10

Toxics of the Environmental Protection Agency 11

for the fiscal year (excluding the amount of any 12

fees appropriated for the fiscal year) are equal to 13

or greater than the amount of appropriations for 14

covered functions for fiscal year 2015 (excluding 15

the amount of any fees appropriated for the fis-16

cal year). 17

‘‘(5) AUDITING.— 18

‘‘(A) FINANCIAL STATEMENTS OF AGEN-19

CIES.—For the purpose of section 3515(c) of title 20

31, United States Code, the Fund shall be con-21

sidered a component of an executive agency. 22

‘‘(B) COMPONENTS.—The annual audit re-23

quired under sections 3515(b) and 3521 of that 24

title of the financial statements of activities 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

341

•S 697 RS

under this subsection shall include an analysis 1

of— 2

‘‘(i) the fees collected under paragraph 3

(1) and disbursed; 4

‘‘(ii) compliance with the deadlines es-5

tablished in section 6 of this Act; 6

‘‘(iii) the amounts budgeted, appro-7

priated, collected from fees, and disbursed to 8

meet the requirements of sections 4, 4A, 5, 9

6, 8, and 14, including the allocation of full 10

time equivalent employees to each such sec-11

tion or activity; and 12

‘‘(iv) the reasonableness of the alloca-13

tion of the overhead associated with the con-14

duct of the activities described in paragraph 15

(2)(A). 16

‘‘(C) INSPECTOR GENERAL.—The Inspector 17

General of the Environmental Protection Agency 18

shall— 19

‘‘(i) conduct the annual audit required 20

under this subsection; and 21

‘‘(ii) report the findings and rec-22

ommendations of the audit to the Adminis-23

trator and to the appropriate committees of 24

Congress. 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

342

•S 697 RS

‘‘(6) TERMINATION.—The authority provided by 1

this section shall terminate at the conclusion of the 2

fiscal year that is 10 years after the date of enactment 3

of the Frank R. Lautenberg Chemical Safety for the 4

21st Century Act, unless otherwise reauthorized or 5

modified by Congress.’’; 6

(2) in subsection (e), by striking ‘‘Health, Edu-7

cation, and Welfare’’ each place it appears and in-8


(3) adding at the end the following: 10

‘‘(h) PRIOR ACTIONS.—Nothing in this Act eliminates, 11

modifies, or withdraws any rule promulgated, order issued, 12

or exemption established pursuant to this Act before the date 13



SEC. 23. DEVELOPMENT AND EVALUATION OF TEST METH-16

ODS AND SUSTAINABLE CHEMISTRY. 17



(1) in subsection (a), in the first sentence by 20




‘‘(c) SUSTAINABLE CHEMISTRY PROGRAM.—The Presi-24

dent shall establish an interagency Sustainable Chemistry 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

343

•S 697 RS

Program to promote and coordinate Federal sustainable 1

chemistry research, development, demonstration, technology 2

transfer, commercialization, education, and training activi-3

ties. 4

‘‘(d) PROGRAM ACTIVITIES.—The activities of the Pro-5

gram shall be designed to— 6

‘‘(1) provide sustained support for sustainable 7

chemistry research, development, demonstration, tech-8

nology transfer, commercialization, education, and 9

training through— 10

‘‘(A) coordination of sustainable chemistry 11

research, development, demonstration, and tech-12

nology transfer conducted at Federal laboratories 13

and agencies; and 14

‘‘(B) to the extent practicable, encourage-15

ment of consideration of sustainable chemistry 16

in, as appropriate— 17

‘‘(i) the conduct of Federal and State 18

science and engineering research and devel-19

opment; and 20

‘‘(ii) the solicitation and evaluation of 21

applicable proposals for science and engi-22

neering research and development; 23

‘‘(2) examine methods by which the Federal Gov-24

ernment can create incentives for consideration and 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

344

•S 697 RS

use of sustainable chemistry processes and products, 1

including innovative financing mechanisms; 2

‘‘(3) expand the education and training of un-3

dergraduate and graduate students and professional 4

scientists and engineers, including through partner-5

ships with industry, in sustainable chemistry science 6

and engineering; 7

‘‘(4) collect and disseminate information on sus-8

tainable chemistry research, development, and tech-9

nology transfer including information on— 10

‘‘(A) incentives and impediments to devel-11

opment, manufacturing, and commercialization; 12

‘‘(B) accomplishments; 13

‘‘(C) best practices; and 14

‘‘(D) costs and benefits; 15

‘‘(5) support (including through technical assist-16

ance, participation, financial support, or other forms 17

of support) economic, legal, and other appropriate so-18

cial science research to identify barriers to commer-19

cialization and methods to advance commercialization 20

of sustainable chemistry. 21

‘‘(e) INTERAGENCY WORKING GROUP.— 22

‘‘(1) ESTABLISHMENT.—Not later than 180 days 23

after the date of enactment of the Frank R. Lauten-24

berg Chemical Safety for the 21st Century Act, the 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

345

•S 697 RS

President, in consultation with the Office of Science 1

and Technology Policy, shall establish an Interagency 2

Working Group that shall include representatives 3

from the National Science Foundation, the National 4

Institute of Standards and Technology, the Depart-5

ment of Energy, the Environmental Protection Agen-6

cy, the Department of Agriculture, the Department of 7

Defense, the National Institutes of Health, and any 8

other agency that the President may designate to 9

oversee the planning, management, and coordination 10

of the Program. 11

‘‘(2) GOVERNANCE.—The Director of the Na-12

tional Science Foundation and the Assistant Admin-13

istrator for Research and Development of the Envi-14

ronmental Protection Agency, or their designees, shall 15

serve as co-chairs of the Interagency Working Group. 16

‘‘(3) RESPONSIBILITIES.—In overseeing the 17

planning, management, and coordination of the Pro-18

gram, the Interagency Working Group shall— 19

‘‘(A) establish goals and priorities for the 20

Program, in consultation with the Advisory 21

Council; 22

‘‘(B) provide for interagency coordination, 23

including budget coordination, of activities 24

under the Program; 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

346

•S 697 RS

‘‘(C) meet not later than 90 days from its 1

establishment and periodically thereafter; and 2

‘‘(D) establish and consult with an Advisory 3

Council on a regular basis. 4

‘‘(4) MEMBERSHIP.—The Advisory Council 5

members shall not be employees of the Federal Gov-6

ernment and shall include a diverse representation of 7

knowledgeable individuals from the private sector (in-8

cluding small- and medium-sized enterprises from 9

across the value chain), academia, State and tribal 10

governments, and nongovernmental organizations and 11

others who are in a position to provide expertise. 12

‘‘(f) AGENCY BUDGET REQUESTS.— 13

‘‘(1) IN GENERAL.—Each Federal agency and de-14

partment participating in the Program shall, as part 15

of its annual request for appropriations to the Office 16

of Management and Budget, submit a report to the 17

Office of Management and Budget that— 18

‘‘(A) identifies the activities of the agency 19

or department that contribute directly to the 20

Program; and 21

‘‘(B) states the portion of the agency or de-22

partment’s request for appropriations that is al-23

located to those activities. 24


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

347

•S 697 RS

‘‘(2) ANNUAL BUDGET REQUEST TO CONGRESS.— 1

The President shall include in the annual budget re-2

quest to Congress a statement of the portion of the an-3

nual budget request for each agency or department 4

that will be allocated to activities undertaken pursu-5

ant to the Program. 6

‘‘(g) REPORT TO CONGRESS.— 7

‘‘(1) IN GENERAL.—Not later than 2 years after 8

the date of enactment of the Frank R. Lautenberg 9

Chemical Safety for the 21st Century Act, the Inter-10

agency Working Group shall submit a report to the 11

Committee on Science, Space, and Technology and 12

Committee on Energy and Commerce of the House of 13

Representatives and the Committee on Environment 14

and Public Works and the Committee on Commerce, 15

Science, and Transportation of the Senate that shall 16

include— 17

‘‘(A) a summary of federally funded sus-18

tainable chemistry research, development, dem-19

onstration, technology transfer, commercializa-20

tion, education, and training activities; 21

‘‘(B) a summary of the financial resources 22

allocated to sustainable chemistry initiatives; 23

‘‘(C) an analysis of the progress made to-24

ward achieving the goals and priorities of the 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

348

•S 697 RS

program established pursuant to subsection (c), 1

and recommendations for future program activi-2

ties; 3

‘‘(D) an assessment of the benefits of ex-4

panding existing, federally-supported regional 5

innovation and manufacturing hubs to include 6

sustainable chemistry and the value of directing 7

the creation of 1 or more dedicated sustainable 8

chemistry centers of excellence or hubs; and 9

‘‘(E) an evaluation of steps taken and fu-10

ture strategies to avoid duplication of efforts, 11

streamline interagency coordination, facilitate 12

information sharing, and spread best practices 13

between participating agencies in the Program. 14

‘‘(2) SUBMISSION TO GAO.—The Interagency 15

Working Group shall also submit the report described 16

in paragraph (1) to the Government Accountability 17

Office for consideration in future Congressional in-18

quiries.’’. 19

SEC. 24. STATE PROGRAMS. 20



(1) in subsection (b)(1)— 23


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

349

•S 697 RS

(A) in subparagraphs (A) through (D), by 1

striking the comma at the end of each subpara-2

graph and inserting a semicolon; and 3

(B) in subparagraph (E), by striking ‘‘, 4

and’’ and inserting ‘‘; and’’; and 5

(2) by striking subsections (c) and (d). 6

SEC. 25. AUTHORIZATION OF APPROPRIATIONS. 7



SEC. 26. ANNUAL REPORT. 10




‘‘(2)(A) the number of notices received during 14

each year under section 5; and 15

‘‘(B) the number of the notices described in sub-16

paragraph (A) for chemical substances subject to a 17

rule, testing consent agreement, or order under section 18

4;’’. 19

SEC. 27. EFFECTIVE DATE. 20


U.S.C. 2601 note; Public Law 94–469) is amended— 22

(1) by striking ‘‘Except as provided in section 23

4(f), this’’ and inserting the following: 24

‘‘(a) IN GENERAL.—This’’; and 25


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

350

•S 697 RS


‘‘(b) RETROACTIVE APPLICABILITY.—Nothing in this 2

Act shall be interpreted to apply retroactively to any State, 3

Federal, or maritime legal action commenced prior to the 4

effective date of the Frank R. Lautenberg Chemical Safety 5



alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

Calendar N

o. 121

11

4T

HC

ON

GR

ES

S

1S

TS

ES

SIO

N

S. 697 A

BIL

L

To a

men

d th

e Toxic S

ubsta

nces C

on

trol A

ct to re-

au

thorize a

nd m

odern

ize that A

ct, an

d fo

r oth

er pu

rposes.

JU

NE

17

, 20

15

Rep

orted

with

an

am

endm

ent


alia

uska

s on

DS

K5V

PT

VN

1PR

OD

with

BIL

LS

calendar no. 121 s s. 697 · 2 •s 697 rs 1 section 1. short title. 2 this act may be cited as the...

Documents